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- 2026-05-11 18:45:40
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- Celltrion Exports COVID-19 treatments to Pakistan
- by Chon, Seung-Hyun May 13, 2021 05:55am
- Regkirona, COVID-19 antibody treatment developed by Celltrion, will be sold overseas. Celltrion Healthcare announced on the 10th that it plans to sign a contract for 100,000 vials of Regkirona with a subsidiary of Pakistan's largest order factories (POF) under the Ministry of National Defense and ship the contract. "Regkirona has been approved for emergency use by certain groups before obtaining official permission from Pakistani health authorities," the company said. Regkirona, which will be sold as the first batch, will be administered to confirmed COVID-19 patients among Pakistani soldiers and ordinary people. 100,000 vials with contracts can be administered to about 30,000 people. Celltrion Healthcare plans to send medical personnel to Pakistan to provide education to local medical personnel who will be in charge of taking Regkirona. Pakistan has the world's fifth largest population of 216.6 million, with an average of about 4,000 new confirmed cases of COVID-19 recently, and the cumulative number of confirmed cases has exceeded 850,000 people. The cumulative death toll from COVID-19 also amounts to 18,000. The situation caused by COVID-19 is getting worse, with the daily average death toll, which was maintained at 50-60 earlier this year, surpassing 150 as of the end of March. "Regkirona, which will be sold this time, will help Pakistan's COVID-19 quarantine policy," Celltrion Healthcare said. Regkirona has been prescribed to more than 2,700 patients since it obtained conditional approval from the MFDS in February for patients with high-risk minor and secondary diseases. Recently, a total of 1,300 global clinical phase III patients have been recruited and administered in 13 countries, including Korea, the United States, Spain and Romania, and data analysis is currently underway. An official from Celltrion Group said, "We are currently discussing Regkirona exports with a number of countries as well as Pakistan. "Considering the limited production capacity of antibody treatments, we plan to focus our support on countries that need help from the international community."
- Company
- Chong Kun Dang challenges New Biologics
- by An, Kyung-Jin May 13, 2021 05:55am
- Chong Kun Dang is a new drug developer and challenges to overcome lung cancer tolerance with a dual anti-cancer antibody that simultaneously inhibits hepatocellular growth factor receptor (cMET) and epithelial cell growth factor receptor (EGFR). It is planning to achieve both business performance and R&D performance with bio-new drugs that it is going to challenge for the first time. Park Kyu-jin, director of Chong Kun Dang, presented the theme of "cMET/EGFR dual antibody development for lung cancer patients" at the 5th Forum on Medical Innovation online event held by the Foundation for Medical Innovation on the 7th. Foundation for Medical Innovation is a non-profit corporation under the Ministry of Science and ICT established in 2016 by Professor Kim Hyo-soo of Seoul National University Hospital, who is considered an expert in cardiovascular, stem cell, and biology. Director Park introduced the main research results of the bio-new drug "CKD-702," which is being developed by Chong Kun Dang, at the forum on the theme of "the latest trends and visions of next-generation bio-innovation technologies." CKD-702 is a dual anti-cancer antibody that simultaneously inhibits c-Met and EGFR, which are essential for cancer growth and proliferation. By binding to each receptor to induce endocytosis and decomposition, the expression of the two receptors is reduced and cancer cell proliferation is suppressed by blocking related sub-signals. It is the first bio-new drug to be challenged by Chong Kun Dang since its foundation. Since launching the development of "CKD-702" in 2013, Chong Kun Dang has completed preclinical verification with the support of the pan-ministry new drug development project. According to the announcement, a preclinical study of CKD-702 exclusively administered to non-small cell lung cancer animal models confirmed that CKD-702 was resistant to EGFR tyrosinase inhibitors (TKI), such as "Giotrip" (Apartmentinib) and "Tagrisso" (Osimertinib). The MET exon 14 skipping mutation or MET gene amplification model, known as one of the major carcinogenes in non-small cell lung cancer, was also shown to significantly inhibit tumor growth only with CKD-702 alone. The results suggest that targeted anti-cancer drugs, which are currently actively prescribed at medical sites, may be overcome. Park Kyu-jin, director of Chong Kun Dang, is introducing the CKD-702 action mechanism at the forum Based on such preclinical data, Chong Kun Dang has been conducting phase 1 clinical tests in Korea since last year for patients with non-small cell lung cancer. It is exploring the possibility of subsequent development by administering CKD-702 solo therapy to those who express specific mutant findings among patients with non-small cell lung cancer. According to Director Park, "CKD-702" has a low binding power to EGFR, which has a low risk of developing skin toxicity, which was considered a side effect of EGFR targeted anti-cancer drugs. On the other hand, cancer cell proliferation ability is better than c-MET target anti-cancer drug and EGFR target anti-cancer drug combined. If preclinical results are reproduced at the clinical stage, the potential is sufficient as the best-in-class in the family, even if it is not the world's first-in-class. Director Park said, "We are targeting non-small cell lung cancer, which mainly expresses c-MET and EGFR, as the first indication. "We are in the process of comprehensively reviewing the possibility of global technology exports or internal development," he said. "We plan to push for global clinical trials by expanding our coverage to stomach cancer and head and neck cancer in the future."
- Company
- HER2-directed ADC ‘Enhertu’ in process of seeking approval
- by Eo, Yun-Ho May 12, 2021 04:43pm
- A HER2-directed antibody-drug conjugate (ADC) is looking to enter the Korean market. According to industry officials, AstraZeneca Korea and Daiichi Sankyo Korea are preparing the application process for the approval of their human epidermal growth factor receptor 2 (HER2)-directed antibody-drug conjugate (ADC) ‘Enhertu (trastuzumab deruxtecan).’ Enhertu, which has indications for breast and gastric cancer, was jointly developed by AstraZeneca and Daiichi Sankyo and was first approved for the treatment of recurrent metastatic HER-positive breast cancer in the U.S. in 2019. Last year, Enhertu was additionally approved in the U.S. for the treatment of locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in patients who have received prior standard treatment with ‘Herceptin(trastuzumab).’ The drug was granted the Breakthrough Therapy Designation (BTD) in the U.S. As Roche’s ADC ‘Kadcyla (trastuzumab emtansine)’ failed to demonstrate its efficacy in gastric cancer, expectations are rising in the field on the possibility of prescribing Enhertu in gastric cancer. Although HER2 protein expression is generally found in breast cancer, it can also be found in other types of cancer. One out of five gastric cancer patients in the U.S. is diagnosed with advanced HER2-positive gastric cancer. The efficacy of Enhertu in gastric cancer was demonstrated through the Phase II DESTINY-Gastric01 trial. In the trial, 25 patients were randomly assigned to receive Enhertu or the investigator’s choice of chemotherapy (paclitaxel or irinotecan) administered by intravenous infusion every 3 weeks. The patients had HER2-positive, locally advanced or metastatic gastric or gastroesophageal junction cancer that had progressed after the patient had received at least two previous regimens, which included Enhertu and fluoropyrimidine-based chemotherapy. Results showed that median overall survival (OS) in the Enhertu group was 12.5 months, which was superior compared to the 8.4 months in the patient group that received the investigator’s choice of therapy. The objective response rate (ORR) was 40.5% in the Enhertu group and 11.3% in the paclitaxel or irinotecan group. Also, the median duration of confirmed objective response was 11.3 months in the Enhertu group, as compared with 3.9 months in the group that received the investigator’s choice of therapy. Also, Enhertu demonstrated efficacy and safety in breast cancer in the Phase II DESTINY-Breast01 trial. Results showed that Enhertu treated group met the primary efficacy outcome measures with an objective response rate (ORR) of 60.9%. The progression-free survival (PFS) was 16.4 months, and Enhertu also showed encouraging duration of response (DoR) and 1-year survival rate outcomes.
- Company
- Can steroid ointment be used for dermatitis?
- by May 12, 2021 05:58am
- Bayer Korea recently released a Pharm drama on the 12th, which consists of cases of chronic dermatitis, atopic dermatitis, and contact dermatitis patients and pharmacists in the form of a drama. The Pharm drama(View Video) is designed to provide guidelines for Bepanthen so that skin inflammation can be safely taken care of without worrying about steroid side effects. Pharmacist Lee Seung-hee, who runs Chunsa Pharmacy, appeared to introduce three cases of skin lesions and conducted an interview on the use of the correct ointment. The three mentioned cases include patients in their 30s suffering from chronic dermatitis due to steroid drug use, infants suffering from atopic dermatitis, and patients in their 30s suffering from contact dermatitis due to wearing masks. The pharmacist first mentioned cases of patients in their 30s suffering from chronic dermatitis, stressing the risk of side effects of steroid drugs. It is explained that stopping after applying steroid drugs for a long time can lead to rebound, which is one of the side effects. Due to the characteristics of steroids, which are immunosuppressants, steroids only improve skin symptoms that are immediately visible, and toxins and heat accumulate steadily in the body. Steroids can be used appropriately depending on the circumstances, but long-term use should be avoided, and it is recommended that the steroid-free ointment be chosen as much as possible. Moisturizing and skin regeneration are needed to alleviate symptoms of atopic dermatitis and contact dermatitis. In particular, Bayer Korea recommended Bepanthen (Dexpanthenol 5%) as an external solvent with these conditions and stressed that it should be treated steadily. Bayer Korea expects the video to help pharmacists consult on medication as more and more patients have skin problems due to wearing masks. In fact, Korean researchers recently announced a study that continued wearing of face masks due to COVID-19 causes skin trouble. It has been confirmed that significant changes in biochemical indicators of the skin are caused by long-term wear of face masks. Wearing a mask for a long time creates a humid environment inside, and skin irritation can occur frequently, causing inflammation, and frequent hand washing and use of sanitizers can also cause skin drying and itching. Chronic dermatitis symptoms such as atopic dermatitis can worsen as the dry and daily temperature range severe weather unique to the change of seasons continues. Pharmacist Lee Seung-hee said, "Bepanthen is an ointment that can be used exclusively for mild skin diseases and can be recommended for those who overuse steroid drugs. It is OTC drug that actually works well for dermatitis." Bepanthen is a non-steroidal ointment that features the effects of skin moisturizers, skin barrier restorants, and wound healing promoters, and ranked No. 1 OTC in the dermatitis treatment category.
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- Will P-CABs take over PPIs in GERD treatment market?
- by Whang, byung-woo May 12, 2021 05:58am
- With HK Inno.N’s K-Cab increasing its influence in the potassium-competitive acid blocker (P-CAB) market, the introduction of new P-CAB products raises the question of whether the products may increase the P-CABs' share in the market. In addition to Daewoong Pharmaceutical’s Fexuprazan, which is expected to be approved in Korea within this year, there are expectations that the already-approved Takeda Pharmaceuticals Korea’s Vocinty (vonoprazan) may also be released this year. Since its introduction, P-CABs were regarded as the next-generation drug that would replace proton pump inhibitors (PPIs) in the market. P-CABs have been known to have resolved most of PPIs' limitations, including the slow onset of action, varied effect according to mealtime, inter-individual variability according to CYP2C19 genotype, and drug interaction concerns. In particular, HK Inno.N’s K-Cab is the world's first P-CAB that received approval for all major indications of gastric acid blockers including erosive and non-erosive Gastroesophageal reflux disease (GERD), It has 4 indications in total. Although reimbursement is not applied to all four indications yet, K-Cab has shown clear growth every year after preoccupying Korea’s P-CAB market. According to the pharmaceutical market data research firm UBIST, since recording 29.8 billion won in sales in 2019, K-Cab’s sales have more than doubled last year to record 72.6 billion won. Also, just in the first quarter of 2021, it already recorded sales of 22.5 billion won. Simple calculations show that if K-Cab’s sales continue at a similar level, the company may surpass 100 billion won in sales this year. However, the industry's prevailing view is that it will take more time to see a shift in the overall market, given that the sales of PPIs are still record around 200 billion won. This is why some predict that if Daewoong Pharmaceutical’s Fexuprazan is approved and released in Korea in the current environment, the rivalry between the two products may actually expand the P-CAB market. An official from A Pharmaceuticals said, “It seems that HK Inno.N’s also knows that the overall share of the pie, the market share of P-CABs in general needs to be expanded to shift the market trend from PPIs to P-CABs. Just like how the PPI market grew due to the introduction of many products in its class, Daewoong Pharmaceutical’s entry into the P-CAB market with its strong sales power will certainly make some waves in the current market situation.” In other words, the rivalry between HK Inno.N and Daewoong’s products may bring synergy in their market. Another product receiving attention in this context is Takeda Pharmaceuticals Korea’s Vocinty. Vocinty, known as the originator of this class of next-gen GERD treatment, was approved in March 2019, but no clear news on its release has been shared yet. An official from Takeda Pharmaceuticals Korea said, “We are working to provide innovative medicines to patients according to our decision-making priorities. However, we cannot disclose specifics on whether or not and when certain products will be released." However, with K-Cab looking to sell over 100 billion won this year and Daewoong Pharmaceutical’s entry imminent in Korea, the industry expects that Takeda may not be able to postpone the launch of Vocinty any longer. However, one obstacle for Vocinty, which is sold under the name Takecab in Japan, is its price. In Japan, the 10mg Vocinty tab. is sold at 130.3 yen (1,339 Korean won) and the 20mg Vocinty tab. is sold at 195.5 yen (2,005 Korean won). This is more expensive than the 50mg K-Cab tab that is currently sold at 1,300 won in Korea. On this, an official from B Pharmaceuticals said, “Many considerations need to be made for a product’s release including the adjustment of its price. However, the company may be able to contemplate much longer, considering the increased P-CAB market in Korea. In addition to Vocinty, which verified its competitivity in Japan, the introduction of Daewoong’s Fexuprazan in the market may trigger a three-way race in the P-CAB market."
- Company
- Trials to suspend refund negotiations for CA drugs fail
- by Chon, Seung-Hyun May 11, 2021 06:00am
- Once again, the pharmaceutical companies have failed to suspend the execution of negotiations for the retrieval of insurance that has been paid for 'choline alfoscerate.' Both of the trials that were filed by two groups of pharmaceutical companies against the health authorities in Korea were dismissed by the court. According to industry officials, the Seoul High Court 1-1 ruled to dismiss the appeal by 28 companies including Chong Kun Dang filed to suspend the execution of negotiations on the retrieval of insurance. After the Seoul Administrative Court rejected the claim for the suspension of execution on January 29th, Chong Kun Dang and the other companies immediately appealed, but to no avail. The court of the second trial also dismissed the case. The law firm Kim & Shin is in charge of the lawsuit. At the end of last year, the Ministry of Food and Drug Safety (MFDS) ordered the National Health Insurance Service (NHIS) to make refunding deals for 230 choline alfoscerate products. The deal, which contains the condition 'If the trial fails, the whole amount of insurance paid for choline alfoscerate drugs that are prescribed from the date the clinical trial protocol is submitted to its the product's deletion from the benefits list shall be paid back in full by the company,' meant the deal was a 'negotiation for the retrieval of insurance.' In other words, the ministry intends to make a contract with the pharmaceutical companies so that when the clinical re-evaluation for choline alfoscerate that is being conducted on order by MFDS fails, the companies would have to pay back all of the insurance received for every prescribed choline alfoscerate drug from the date the clinical trial protocol was submitted to the date their license is revoked. Pharmaceutical companies have unanimously filed an administrative suit and complaint to suspend the execution of the order to pay back the insurance for choline alfoscerate drugs. The companies divided into two groups for the lawsuit. Lee&Ko is in charge of the suit for the 28 companies including Daewoong Bio, and Kim & Shin is in charge of the suit for the 28 companies including Chong Kun Dang. Daewoong Bio and the other companies have filed for the suspension of execution on December 30th of last year, but the first and second trials were both dismissed. The second trial was turned down on February 4th, a month after the case was filed, and the case is currently pending in the Supreme Court. Chong Kun Dang. and the other companies filed their complaint to suspend execution on January 8th of this year and received the dismissal ruling on January 29th. Chong Kun Dang and the companies appealed, but the case was again dismissed in the second trial recently. The administrative suit on choline alfoscerate has not been ruled yet. The Daewoong Bio's group and the Chong Kun Dang's group have both filed suits to the Seoul Administrative Court to cancel the negotiation order and notification, against the MFDS and NHIS separately. The cases of the two groups are to be merged for review, and the first proceedings are scheduled in July. Recently, NHIS failed to reach an agreement with pharmaceutical companies regarding the reimbursement of their choline alfoscerate products. NHIS and the companies were unable to reach an agreement after extending the negotiation period two times. As a result, the MFDS will have to delete the products from the benefits list or order renegotiations.
- Company
- The cobas SARS-CoV-2 & Influenza A/B Test was approved
- by May 10, 2021 05:56am
- Roche Diagnostics Korea announced on the 6th that it has obtained permission from the MFDS to "cobas SARS-CoV-2 & Fluenza A/B," which can diagnose COVID-19 and flu at the same time. The cobas® SARS-CoV-2 & Influenza A/B Test is a multiplex reverse transcription polymerase chain reaction (RT-PCR) assay intended for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus in nasal or nasopharyngeal swab samples collected from individuals suspected of a respiratory viral infection consistent with COVID-19 by their healthcare provider. It is based on automated molecular diagnostic equipment 'covas 6800' and 'covas 8800', and can proceed from nucleic acid extraction to gene amplification, test, result analysis, and report through one-stop automation method. The cobas 6800 provides 384 tests per eight hours and the cobas 8800 provides 960 tests. The intervention of personnel to replace reagents and consumables reduced the cobas 6800 to once every eight hours and the cobas 8800 to once every four hours, respectively, improving the convenience of the medical staff's COVID-19 test. This automated test prevents errors caused by manual work through an all-in-one solution that is inspected in a single equipment from extracting nucleic acids to producing test results, and also reduces the risk of contamination caused by external substances. The cobas SARS-CoV-2 & Influenza A/B confirmed over 97% sensitivity and specificity through clinical studies. For COVID-19, the sensitivity associated with the false (fake-positive) risk was 100.00%, and the specificity associated with the false (fake-positive) risk was 99.82%. For influenza A, sensitivity and specificity were 97.14% and 99.04% respectively, and for influenza B, sensitivity and specificity were 100.00%. The cobas SARS-CoV-2 & Influenza A/B was approved for EMA by the FDA in September 2020 and obtained European Medical Device Certification (CE) in the same month. Johnny Tse Roche, CEO of Diagnostics Korea, said, "We expect high-capacity fully automatic cobas SARS-CoV-2 & Fluenza A/B not only improves the speed and convenience of testing, but also helps prevent the spread of infections and provide appropriate treatment for patients."
- Company
- The trend to advertise vaccines is diversity and young men
- by May 07, 2021 06:02am
- GSK Rotarix model Jo Jeong-seok, MSD Gardasil9 model Jeong Gyeong-ho, Yoo Byeong-jae, Jo Se-ho, and Pfizer Pharmaceutical PREVENAR13 model Choi Gwi-hwaVaccine advertisements by pharmaceutical companies are diversifying. Instead of the flu vaccine, it has diversified into vaccines for rota virus, pneumococcus, cervical cancer, and whooping cough. This is to raise awareness of vaccinations for vaccines that have not been well-known until now as interest in preventing infectious diseases has increased due to COVID-19. The main model was a young male entertainer. According to the pharmaceutical industry on the 7th, MSD Korea is the most active. MSD selected singers Mommy Son, comedian Jo Se-ho and Yoo Byung-jae as models for the advertisement of the HPV virus (cervical cancer) vaccine Gardasil9 only last year. Also recently, actor Jung Kyung-ho was selected as the new Gardasil 9 model. The reason MSD has introduced a variety of male models is to emphasize the importance of vaccination against the HPV virus in men. Until now, the HPV virus vaccine was widely known as a cervical cancer vaccine, so there was a strong recognition that it was only suitable for young women. However, although this virus is rare, it can also cause anal cancer and genital warts in men. As a result, MSD, which focused on women's marketing with comedian Park Na-rae as a model, began to use a large number of young male models to improve awareness. Mami Son's rap and Jo Seho and Yoo Byungjae's parody competition aroused the interest of young men. In April, it emphasized a clean concept with actor Jung Kyung-ho as a model. GSK also introduced actor Jo Jung-seok, who is considered the best advertising star since August of last year, as a model of the rotavirus vaccine Rotarix. His credible image and comfortable voice are favored by young people, regardless of gender. In particular, Rotavirus vaccine is suitable for newborns, and at the time of selection, Jo Jung-seok also became a parent with the child. This is Rotarix first public TV commercial. GSK said, "To inform the necessity of vaccination against Rotavirus that does not apply to NIP, and to raise brand awareness, we will conduct a public advertisement with Jo Jung-seok." GSK also launched a public TV commercial for the whooping cough vaccine Boostrix this year. Since the main target of Boostrix is adults over 50, we decided to be the main model as actor Seong Dong-il. GSK emphasized the importance of vaccination by arousing the attention of silver generations to whooping cough with Boostrix advertisements. GSK introduced various versions of Boostrix advertisements, and raised consensus with the camping entertainment program" the Wheeled House Camping Edition' starring Sung Dong-il. Pfizer Pharmaceuticals selected actor Choi Gwi-hwa as a new model for the pneumococcal vaccine PREVENAR13 in November of last year. As interest in pneumococcal vaccine increased amid the COVID-19 crisis, a public TV advertisement was held in two years. Choi Ki-hwa, with his wife, child, and grandparents going to receive PREVENAR13, appealed to the point that it is a vaccine that is suitable for the whole family. The number of vaccine advertisements, which had not been in public marketing until now, has increased, but the widely-known flu vaccine advertisement has somewhat slowed down. In 2019, GSK, GC Pharma, and SK Bioscience showed active public advertisements, led by actors Cha In-pyo and Yoon Se-ah, but last year the frequency of advertisements decreased significantly. Sanofi Pasteur was the only one to run an advertisement with singer Song Ga-in as a model for Vaxigrip. It is analyzed that this was affected by the widening of NIP targets due to COVID-19.
- Company
- Cherry Huang to succeed Jenny Zheng as head of Janssen Korea
- by Eo, Yun-Ho May 07, 2021 06:01am
- Janssen will continue to have a foreign leader head its Korean subsidiary. According to industry sources, Janssen Korea has appointed Cherry Huang as the next CEO of Janssen Korea to take Jenny Zhuang’s place after Zhuang’s term ends in April. Cherry Huang, who is currently the CFO of Janssen Asia Pacific, will be leading Janssen Korea from June this year. Hwang had served over 20 years in Johnson & Johnson since 1997 and has held various finance roles within the company. She had built her career in finance in various regions including in the Southeast Asian cluster, China, and Singapore. With Jenny Zhuang’s transfer, the board of directors (BOD) of the Korean Research-based Pharmaceutical Industry Association has also undergone some change. Following the resignation of Jenny Zhuang as director, KRPIA appointed Hye-young Lee, CEO of Viatris Korea as its new board director. Zheng has served as the Area Managing Director of Janssen Korea/Taiwan/Hong Kong since 2018. She holds a Bachelor of Engineering, Naval Architecture degree from Shanghai Jiao Tong University, and completed her Master of Business Administration (MBA) with Honors from the University of Chicago Booth School of Business.
- Company
- “Evenity is effective in patients at very-high-risk of OP"
- by May 07, 2021 06:01am
- The strategic paradigm for osteoporosis treatment has shifted. Compared to the past where not many patients were treated for osteoporosis and those who were treated used bone resorption inhibitors like bisphosphonate, a more aggressive treatment paradigm has landed in the field of osteoporosis treatment. The development of new drugs had triggered such changes in the treatment trend. Unlike bone resorption inhibitors, the only option patients used to have as a bone-forming agent was teriparatide; however, the introduction of Amgen’s ‘Evenity (romosozumab)’ brought all the difference. Evenity is the first and only bone builder with a dual mechanism of action that increases bone formation and inhibits bone resorption. With the introduction of this promising new drug, the American Association of Clinical Endocrinology∙American College of Endocrinology (AACE∙ACE) newly defined a Very-high-risk group for osteoporosis fractures by revising the 2020 guidelines for the diagnosis and treatment of postmenopausal osteoporosis, to recommend aggressive drug treatment from early on. Dailypharm met with Dr. Felicia Cosman, professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons, to hear about the latest advances and trends in the treatment of osteoporosis. Professor Felicia Cosman. Dr. Cosman is explaining the latest advances in the treatment of osteoproosis in a virtual webinar held on the 4th. (Pic. From the virtual interview) -- Last year, the international guideline newly defined the 'very-high-risk group for osteoporosis fracture' and presented different treatment strategies according to the patient’s level of risk. Could you tell us the background and specifics of the revised guideline? =Academic societies in Korea and abroad have newly defined patients with high risk of fractures as a ‘very-high-risk group for osteoporosis fracture’ and recommends bone-forming agents to be more effective in increasing bone strength. These group of patient can be considered ‘at emergency of osteoporosis’ and are at high risk of experiencing fractures in the near future. The international osteoporosis foundation defined the very-high-risk group for osteoporosis fracture as ‘patients with a 10% or higher probability of experiencing fractures within 2 years.’ Also, according to a retrospective cohort study by Professor Balasubramanian that researched 377,561 women that are 65 years or older who recently experienced fractures, the cumulative risk of subsequent fractures in these women were 10% and 18% in 1 and 2 years, respectively. One notable fact is that the risk and area of subsequent fractures varied according to the initial fracture site. Patients with initial vertebral fracture had the highest risk of refractures at 14%, and those with initial ankle fracture had the lowest risk at 5%. However, as the 2-year risk of refracture in patients with ankle fractures was also 10%, these patients were also categorized as a very-high-risk group. Multiple fracture patients are also classified as a very-high-risk group, regardless of their recent fracture events. This very-high-risk group should use bone-forming agents from early on for rapid bone formation. In the past, bone resorption inhibitors were considered as the first treatment option for these patients; however, the paradigm has shifted to using bone-forming agents from early on. -The new guidelines recommended 4 kinds of treatment strategies for the very-high-risk group. Evenity, which shows a dual effect to increase bone formation and inhibit bone resorption, was also first recommended in the revised guidelines. What is your opinion on this, and how should we devise treatment strategies using the recommended therapies? =As I mentioned before, the paradigm has changed to acknowledge that starting treatment with bone-forming agents like Evenity, followed by bone resorption inhibitors may be more effective for bone formation. This is why Evenity was also included as an option in the new guideline. There aren’t many head-to-head studies on Evenity and teriparatide; however, there is one that was published on NEJM in 2014. The Phase II trial that studied women aged 55 to 85 with low bone mineral density showed that Evenity had improved the BMD in hip, femoral neck and spine more than teriparatide. Evenity also had a higher effect in increasing bone density compared to teriparatide in the hip and spinal area a follow-up study, In practice, the approach needs to be set differently for each patient. For example, a patient in his/her 60s who had experienced spinal fracture may have a low BMD in his/her spine, but a normal BMD in the hip area. If the patient has no other risk factors, he/she may choose to use teriparatide. -As the lead author of the Phase III FRAME (FRActure study in postmenopausal woMen with ostEoporosis) trial, you found that Evenity-Prolia was more effective in reducing the risk of fracture than placebo-Prolia. =The FRAME study compared patients treated with Evenity and placebo for 1 year, both followed by Prolia for 1 year to assess the risk of fractures. Study results showed that at month 12, Evenity reduced the risk of new vertebral and all clinical fracture risk by 73% and 38%, respectively, compared to placebo. Also, patients treated with Evenity saw a mean percent increase in BMD over placebo of 13.3% at the lumbar spine, 6.8% at the total hip, and 5.2% at the femoral neck. This is a superior increase in BMD compared to both mono and dual therapies. Based on such results, the researchers were able to reconfirm that Evenity is the top priority treatment option for patients at very high risk of fractures as it quickly reduces the risk of fractures while increasing bone formation. In particular, Evenity is more suitable for patients with a low BMD in the hip and nonvertebral areas, as well as the vertebrae area. -Despite Evenity’s potency, why do patients need to switch to Prolia after 1 year? Could patients who saw much benefit from Evenity extend their treatment period? =The treatment period reflects the results of the Phase II trial on Evenity. In the Phase II trial, Evenity showed a very high bone-forming effect for 1 year. After that, its effect was comparable to those of bone resorption inhibitors. While no additional benefits were seen in the second year of Evenity treatment, such as an increase in bone mass, patients who switched to Prolia after 1-year of Evenity treatment saw the better effect. Based on such findings, the 1-year treatment period was deemed reasonable considering the administration cycle and number. -- What are your thoughts on the risk of adverse cardiovascular events that were added to the indications in Europe, U.S., and Korea? =The only clinical study on Evenity that presented adverse cardiovascular events was the Phase III ARCH trial that compared Evenity with alendronate. In the study, a higher rate of major adverse cardiac events (MACE), which is defined as the composite of cardiovascular deaths, myocardial infarction, or stroke, was reported at week 12 in patients treated with Evenity (2.0%, 41/2,040 participants) compared to those treated with alendronate (1.1 %, 22 /2,014 participants). However, when including heart failure events, there was no significant difference in MACE between the two groups. In conclusion, the risk and benefits that each patient may see from using Evenity need to be analyzed and compared. Of course, the decision must comply with the recommendations set in the approval process. In the U.S., use of Evenity is restricted for patients that are at very high risk of experiencing cardiovascular events. This includes patients who have experienced strokes or myocardial infarction within 1 year. -In Korea, the reimbursement standards directly affect treatment strategy. In consideration of the reimbursement standards currently set for Evenity in Korea, what areas do you think require further discussion? = When I saw Korea’s reimbursement criteria for Evenity, I wondered whether its application after 2 or more fractures was appropriate. As I have mentioned before, there is ample evidence to support the validity of prescribing Evenity even after just a single fracture. Also, the criteria that first requires the use of bisphosphonates is quite similar to the pre-revised international guideline. The problem is that prescribing bone-forming agents after the use of bisphosphonates doesn’t provide as good an effect in reducing fractures. Korea also needs to consider the paradigm shift in osteoporosis treatment that has already begun. In the past, the global consensus was to first use bisphosphonate; however, this has completely changed now. With the introduction of Evenity, it has been recognized that the right time to use bone-forming agents for optimal effect is in the early stages when patients are identified to be at very-high-risk of fractures.
