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- 2026-05-15 22:34:48
- Policy
- The use of Benzalconium chloride is not interrupted
- by Lee, Hye-Kyung Jun 27, 2022 05:58am
- As a result of reviewing the feasibility of safety management measures for drugs containing Benzalconium chloride used as humidifier disinfectants, it was concluded that there was no basis for restricting the use of drugs. Benzalconium chloride is used as daily necessities such as hand sanitizers, nose sanitizers, eyewash, preservatives, preservatives, antibacterial tissues, floor cleaners, and other medicines such as surgical tool disinfectants and skin disease treatments. According to the minutes of the Central Pharmaceutical Review Committee recently released by the MFDS, the safety of Benzalconium-containing drugs should be considered separately from repeated inhalation toxicity tests of Benzalconium chloride conducted by the Ministry of Environment. In the case of drugs, it is tested at 100% purity, but according to the repeated inhalation toxicity test conducted by the Ministry of Environment, the purity of Benzalconium chloride is 50.5%, which is not suitable for the toxicity test criteria for drugs. Although the nasal spray containing Benzalconium chloride has been used for a long time, there are no data that the product has caused problems in the respiratory system so far, so there were opinions that excessive information could cause fear to users. When comprehensively reviewing related data such as conference data, it is not enough evidence to stop using Benzalconium chloride in medicines based on the Ministry of Environment's report on repeated inhalation toxicity. The prevailing opinion was that the MFDS should end up with strengthening safety use and changing permits for information disclosure rather than suspending the use of Benzalconium-containing drugs. The MFDS said, "As a result of a comprehensive review of safety, efficacy, and adverse reactions, it should be judged in consideration of benefits and risks in medicines. We will collect opinions from external experts and provide accurate information." Rather than reflecting safety information only on precautions for use, it is necessary to ensure that meaningful information is delivered for patients who have no choice but to use drugs containing Benzalconium chloride, such as asthma treatments, according to their doctor's instructions, said a member. The MFDS reviewed various measures such as inquiring opinions on changing usage precautions to provide accurate information to consumers, and expressed its opinion that it would communicate between related ministries.
- Company
- This time it’s acyclovir… impurity issue rises again
- by Chon, Seung-Hyun Jun 27, 2022 05:57am
- The drug impurity risk issue has spread to the antiviral acyclovir. According to the impurity issue that arose abroad, the health authorities have started making safety measures on pharmaceutical companies. According to industry sources on the 23rd, the Ministry of Food and Drug Safety has recently ordered pharmaceutical companies to conduct a review for N-nitrosodimethylamine (NDMA) impurities on finished drugs that contain acyclovir. The MFDS has ordered the companies to submit test results conducted on the companies’ representative batch numbers of the finished acyclovir products available on market. Products that are manufactured in below 3 batch numbers are required to submit test results of all batches This safety measure was made according to the safety information that finished tablet products containing acyclovir were recalled abroad due to excess NDMA impurities. The MFDS ordered companies to immediately report their test results after completion even before the impurity data submission deadline. Acyclovir is an antiviral used for the ‘treatment and prevention of initial and recurrent genital herpes, Herpes Simplex Virus Encephalitis, and Mucocutaneous Herpes Simplex Virus Infection’ as well as for the ‘treatment of herpes zoster (Shingles).’ Its annual outpatient prescriptions amount to 15 billion won a year. This is the first time an impurity issue arose in the area, and around 50 companies sell acyclovir tablets in Korea. With acyclovir, the total number of ingredients with new impurity risks increased to 3. The MFDS had previously requested pharmaceutical companies to investigate their montelukast imported and manufactured APIs and finished products for N-nitrosodipropylamin (NDPA) impurities and submit its results in January. In April, the MFDS had ordered pharmaceutical companies to submit data including the impurity test results and data on the possibility of N-Nitroso-Aryl Piperazine (NNAP) impurities in quetiapine products.
- Company
- Belvarafenib confirmed its safety & effectiveness
- by Chon, Seung-Hyun Jun 27, 2022 05:57am
- Major clinical results of Belvarafenib + Cobimetinib included in Roche corporate briefing dataA study showed that the new anticancer drug Belvarafenib, which Hanmi Pharmaceutical exported technology to Genentech, confirmed its safety and effectiveness overseas. According to Hanmi Pharmaceutical on the 22nd, Roche revealed the progress of clinical research on "Belvarafenib," which is being developed by its subsidiary Genentech, at a corporate briefing held during the recent ASCO event. Belvarafenib, which Hanmi Pharmaceutical exported to Genentech in 2016, is a targeted anticancer drug based on pan-RAF inhibitors. It acts as a mechanism to suppress RAF, a type of MAP kinase that mediates intracellular signaling. Hanmi Pharmaceutical received $80 million in a contract for the export of Belvarafenib technology. Roche introduced data on the efficacy and safety of patients with NRAS mutated melanoma identified as clinical trials (1b) for combined administration of Belvarafenib and Cobimetinib (MEK inhibitor) in 118 patients with different types of solid cancer with RAF or RAS mutations. According to the announcement, 26.3% of NRAS mutated melanoma patients administered belvarafenib and Cobimetinib showed partial response (PR), and 42.1% of patients reached stable lesion (SD). The median value of the total progression-free survival period (PFS) was 7.3 months. No new adverse reactions were observed beyond the safety of individual drugs. All patients who showed partial reactions were NRAS mutant melanoma patients with a history of treatment with Imune checkpoint inhibitor, and this result could show new hope for patients who recurred after Imune checkpoint inhibitor treatment, Hanmi Pharmaceutical explained. "Belvarafenib, developed by Hanmi Pharmaceutical, is a powerful selective RAF mutation inhibitor," said Andrew Chan, managing director of Genentech. "We confirmed its safety and anti-tumor effects when administered in combination with Cobimetinib in patients with NRAS mutated melanoma who previously received Imune checkpoint treatment." An official from Hanmi Pharmaceutical said, "Innovative anticancer drugs developed and exported by Hanmi Pharmaceutical are being developed smoothly based on close consultation with partners," adding, "We will focus more on R&D capabilities for rapid commercialization of various innovative drugs, including Belvarafenib."
- Company
- The flu is going around in the southern hemisphere
- by Whang, byung-woo Jun 27, 2022 05:57am
- Concerns are growing that the influenza epidemic may begin as the COVID-19 pandemic turns into an endemic and social distancing such as lifting outdoor masks is eased. As the flu is showing signs of a full-fledged epidemic in Australia, one of the southern hemisphere countries that uses the flu as an indicator of the flu epidemic in the second half of the year, concerns are also being raised. It is pointed out that it is necessary to prepare countermeasures as the flu vaccination rate has fallen due to the influence of the COVID-19 pandemic over the past two years, and there may be repercussions from the release of masks. In the case of the flu epidemic, the epidemic scenario in the northern hemisphere is often calculated based on the situation in the southern hemisphere in the first half of the year. As winter comes first in the southern hemisphere, it is to guess the trend of infectious diseases. According to the Australian Influenza Surveillance Report (AISR), published biweekly by the Department of Health, the number of patients with flu symptoms in Australia has increased since March this year. In May, Australia's medical institutions confirmed influenza viruses in samples such as patient sputum and runny nose and reported more than 25,000 cases to the Ministry of Health per week, and by early June, 87,989 cases were reported to Australia's NNDSS, of which 47,860 occurred in late May and early June. This is a rapid increase compared to data from the past five years, and the gap is wider considering that the flu epidemic has not occurred due to COVID-19 in the past two years. In the end, it is pointed out that the same phenomenon may occur during the domestic flu epidemic in the second half of the year. Jung, Ki-seok, a professor of respiratory medicine at Hallym University Sungsim Hospital, said, "I don't know how much more exchanges between countries will occur in the second half, but I think the domestic flu will be the same." He said, "It is also difficult to predict the presence or absence of new mutations in COVID-19, but I think it is highly likely to be prevalent once more." Choi Young-joon, general director of the KSPID (Korea University's Department of Pediatrics and Adolescents), also said, "We say that the epidemic will be this year because we haven't caught much flu over the past two years," adding, "There has been no local transmission and there is a high possibility of infection." Companies such as Pfizer and Moderna have started to develop Combo vaccines that inoculate flu vaccines and COVID-19 vaccines at once, but as they have not yet succeeded in developing them, it is also the best countermeasure to plan individual vaccination plans at this stage. During the COVID-19 pandemic, the number of vaccinations increased significantly due to concerns over twin-demic during the 2020 vaccination period, but the site explained that NIP-oriented flu vaccinations were made in 2021. Vice Chairman of the KIES Shin Kwang-chul said, "In 2020, I have been vaccinated the most and I remember securing as many flu vaccines as possible," adding, "But last year, we set the demand for flu vaccines low enough to order only 30% of the quantity in 2020." With the possibility of a flu epidemic, companies that produce flu vaccines are also getting busy. As SK Bioscience has not produced a flu vaccine this year following last year, domestic companies and multinational pharmaceutical companies are filling it up. Sanofi Pasteur has already submitted to supply 2.2 million doses per dose at 10, 433 won per dose in connection with the procurement of the national vaccination (free flu vaccine vaccination project) for influenza vaccines, and has been selected as the top priority. 3 million doses of flu vaccine for Ilyang Pharmaceutical, which previously included NIP, are expected to be vaccinated in the private market. Already on the 18th of last month, U.S. health authorities began discussing ways to vaccinate flu and coronavirus at the same time in preparation for the simultaneous spread of COVID-19 and flu in winter. There are negative opinions due to concerns over the stability of vaccinating two vaccines, but we cannot ignore the situation in which twin-demise will occur. Domestic experts also say that it is necessary to consider temporarily expanding the scope of NIP as well as vaccinating COVID-19 and flu vaccines at the same time. Professor Jeong said, "There will be no big problem because the guidelines have already been set for inoculating two types of vaccines with one arm on each side." "If the flu vaccine epidemic is expected, we think it will be necessary to think about expanding the NIP range as we did before," he said.
- Policy
- Is "Platform of Drug Delivery" starting?
- by Lee, Jeong-Hwan Jun 24, 2022 05:46am
- The Ministry of Science and Technology recently decided on the demonstration exception of OTC teleconference bending machine at the 22nd ICT regulatory sandbox meetingWill the new government's implementation of the OTC teleconference bending machine demonstration special case serve as a signal for full-fledged activation of the "drug delivery platform"? Analysts say that as the government introduced the OTC teleconference bending machine, which is virtually not allowed by the Pharmaceutical Affairs Act, regulations on platform operators such as drug delivery apps are also likely to be eased significantly in the future. In particular, the Ministry of Science and ICT seems to be more proactive in looking at deregulation as the situation develops rather than the MOHW at the forefront of management and regulation of non-face-to-face treatment and drug delivery apps. On the 23rd, the health and medical community is paying keen attention to the direction of the new government's digital platform policy operation. Yoon Seok-yeol's government has decided to foster the digital online platform industry as a national task. In order to revitalize new industries, it is in a position to boldly break down existing regulatory barriers and collect opinions from industries quickly and actively. The OTC teleconference bending machine regulation special case seems to be the result of reflecting this new government policy. The problem is that the OTC teleconference bending machine is a regulatory exception that is relatively local and has little ripple effect. Digital platform technology is not used in that electronic devices are installed inside and outside existing pharmacies to allow the sale of general drugs in some efficacy groups with the pharmacist's OTC teleconference bending machine medication map. In the end, it is evaluated that deregulation of digital platforms in the health care sector will gradually flow in the direction of activating drug delivery platforms. The new government is implementing a one-sided policy of deregulation of digital platforms every day. The Ministry of Science and Technology is planning to lead the promotion of platforms by jointly announcing strategies for developing digital platforms within this year. Minister of Science and Technology Lee Jong-ho recently held a policy forum with digital platform companies such as Naver, Kakao, and Coupang and promised to "establish a private-led self-regulatory organization." The plan is to increase the effectiveness by providing legal grounds for establishing and supporting self-regulatory organizations so that the private sector, not the government, can set up platform regulations on its own. Of course, health and medical platform companies such as drug delivery apps did not attend the forum, but the wider the scope of the government's promotion of the platform industry, the more likely the drug delivery apps will also benefit from deregulation. The opposition Democratic Party of Korea is expressing some concern about the stance of the new government. Even if the digital platform industry is fostered, the Democratic Party of Korea believes that deregulation should be applied conservatively in health care fields such as non-face-to-face treatment and drug delivery apps. It's directly related to national health It takes into account the fact that it can bring considerable shock waves to the health care delivery system such as local clinics and the ecosystem of pharmacies. An official from the Democratic Party's policy committee said, "The OTC teleconference bending machine was applied by the government to the regulatory sandbox track after it was put on hold during the legislative debate in the National Assembly. Although it was allowed, I don't think the actual ripple effect will be significant, he said. "However, there will definitely be an effect of activating platform operators such as drug delivery services." The OTC teleconference bending machine is an agenda limited to pharmacists in a way, but the activation of health care platforms such as non-face-to-face treatment and drug delivery apps will have a great impact on the medical community and the pharmaceutical community, the official said. It will be necessary to respond to platform regulations in the health care sector," he added.
- Company
- Sanofi’s Allegra dominates OTC·ETC drug market
- by Nho, Byung Chul Jun 24, 2022 05:46am
- The market for OTCs and ETCs of the antihistamine ingredient fexofenadine hydrochloride has been showing stagnant performance with its sales making a rectangle pattern for several years now. The market is virtually monopolized by the original drug, Sanofi’s Allegra Tab., with the total market estimated to be in the ₩8 billion range. One aspect to note is that the high-dose 120mg Allegra Tab. is listed for reimbursement as an OTC, and the other 180·60·30mg strengths of Allegra are distributed and prescribed as ETCs in Korea. This is analyzed as a strategic decision made by the company in consideration of the clinical protocol, design, and efficacy of its drug. Allegra is in the undisputed lead among fexofenadine hydrochloride OTCs, showing a vendor performance of ₩2-3 billion. Hanmi Pharmaceutical's Fexonadine, Huon’s Allerdin, and Chong Kun Dang’s Pecsone 120mg had sold ₩350 million, ₩150 million, and 120 million each, respectively. These latecomers were all released around 2005 and 2008, and all three drugs are all listed at ₩226 per tablet. The price of Sanofi’s finished imported pharmaceutical, the OTC Allegra, has been discounted to ₩225/tablet in 2017, ₩224/tablet in 2018, then to ₩222 in 2022, and is currently sold at a lower price than its domestic latecomers. Allegra and other OTC drugs with identical APIs that are effective in alleviating symptoms of allergic rhinitis are recommended to be administered with caution in patients with kidney failure, cardiovascular disease, or old age, and require particular medication guidance on the pharmacist’s part. In addition, its related ingredients are classified as pregnancy risk category C, and are used when there is a clear clinical basis or reason for its inevitable use. In the fexofenadine hydrochloride ETC market, the original, Sanofi’s Allegra and its bioequivalent, Hanmi Pharmaceutical’s Fexonadine are in a two-way battle. Allegra 180mg sold ₩3.1 billion, Fexonadine 180mg ₩870 million last year, and Allegra 30mg ₩240 million, Fexonadine 30mg ₩140 million. The 180mg strength of Allegra that was approved in 2000 is used to treat allergic dermatitis, and its price had been reduced to ₩314/tablet in 2017, ₩313/tablet in 2018, ₩312/tablet in 2020, and then to ₩311/tablet in 2022. The price of Allegra 60mg is currently set at ₩181/tablet and is effective in relieving symptoms of seasonal allergic rhinitis. According to the insert paper, etc. patients with hypertension, diabetic kidney disease, hyperthyroidism, and benign prostatic hyperplasia are requested to consult with their doctor, dentist, or pharmacist before taking the drug. Allegra 30mg, which is priced at ₩91/tablet, is prescribed to relieve symptoms of seasonal allergic rhinitis and allergic dermatitis. Hanmi Pharmaceutical’s Fexonadine 30mg, which was approved as a bioequivalence-assured product in 2007 is listed at ₩91/tablet, at the same price as the original drug. Meanwhile, one point of interest is in their distribution. The distribution of Allegra is dualized so that the OTCs are directly managed by Sanofi while the ETCs are imported and sold by Handok Pharmaceuticals.
- Company
- Yuhan’s new lung cancer drug Leclaza shows OS benefit
- by Nho, Byung Chul Jun 24, 2022 05:46am
- Yuhan Corp (CEO and President Wook Je Cho) announced on the 23rd that it had confirmed the overall survival (OS) benefit of Leclaza (lasertinib) in the Phase I/II LASER201 trial (NCT03046992). Leclaza is a treatment for epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC). Leclaza is a third-generation oral EGFR Tyrosine Kinase Inhibitor (TKI) that has high selectivity against the EGFR T790M resistant mutation. The drug showed superior efficacy and safety in NSCLC patients with brain metastasis as it can pass through the blood-brain-barrier (BBB). Lecalza’s OS results had been presented at the AOS 2022 & KCA Annual Meeting 2022 which was held from the 16th to 18th of this month. The OS results were updated from the Phase I/II LASER201 trial that had been the basis for Leclaza’s approval in Korea. The Phase I/II trial evaluated the efficacy and safety of continuous daily oral administration of Leclaza 240mg on 78 adult patients with EGFR mutation-positive NSCLC whose disease had progressed after EGFR TKI at 17 centers in Korea. Analysis results on the 76 patients with EGFR T790M mutation-positive patients showed that the median overall survival (mOS) was 38.9 months. Ji-Youn Han, Professor of Hemato -Oncology at the National Cancer Center who presented Leclaza’s OS results at the AOS 2022 & KCA Annual Meeting 2022, said, “It is encouraging that the mOS of EGFR T790M mutation-positive patients who are at high risk of brain metastasis had reached 38.9 months in the study, showing over 3 years of survival. Also, Leclaza is associated with the superior effect of achieving median intracranial progression-free survival (mPFS) of 26 months in patients with measurable brain lesions (25 patients).” Han added, “When considering that the ultimate treatment goal of treating cancer patients is in extending life, the OS benefit identified in the trial shows potential to extend life expectancy in T790M mutation-positive patients.” Meanwhile, the latest results of the Phase I/II LASER201 trial had previously been published in the April edition of the Journal of Thoracic Oncology (JTO), the official journal of the International Association for the Study of Lung Cancer (IASLC). Yeol-Hong Kim, Professor of Hemato Oncology at Korea University Anam Hospital, who is also the President of the Asian Oncology Society, said, “It is meaningful that Leclaza’s OS benefit had been presented at the AOS 2022 & KCA Annual Meeting 2022. The fact that Leclaza, a novel homegrown lung cancer drug, has demonstrated an mOS of 38.9 months in the second-line treatment of EGFR mutation-positive NSCLC is remarkable. The results show the possibility that Leclaza could bring a new turning point to the lung cancer treatment landscape in the future.” Wook Je Cho, CEO of Yuhan Corp, said, “We are pleased to share the news that Leclaza showed an OS benefit that meets the expectations as a novel homegrown lung cancer drug. Yuhan Corp will continue to make efforts, including completing the ongoing clinical trials and global commercialization so that Leclaza can become a useful treatment option for patients suffering from EGFR mutation-positive NSCLC in Korea and around the globe. Meanwhile, Yuhan is currently conducting a multinational Phase III trial (LASER 301) to evaluate the efficacy and safety of Leclaza as a first-line treatment in patients with EGFR mutation-positive NSCLC, and the top-line results of the Phase III trial are expected to be disclosed by the end of this year. A global Phase III trial on the combination of Leclaza with amivantamab, Janssen’s fully human bispecific antibody targeting both EGFR and MET, is also in progress.
- Policy
- A suspected Monkeypox patient entered Korea
- by Lee, Jeong-Hwan Jun 24, 2022 05:46am
- With two suspected Monkeypox infections confirmed to have entered Korea, President Yoon ordered accelerated approval of vaccines and antiviral drugs from quarantine authorities. On the 22nd, President Yoon ordered, "Strengthen the management of entry and quarantine through airports and closely monitor the additional occurrence in Korea." Currently, the quarantine authorities are conducting tests on one foreigner suspected of being infected with Monkeypox and one Korean among domestic arrivals. A suspected foreign infection entered the country by air on the 20th. From the 19th, blistering skin lesions occurred along with systemic symptoms such as sore throat and lymph node disease, and visited a hospital in Busan on the morning of the 21st. The hospital reported a suspected foreigner as a suspected monkeypox case and is currently being treated in an isolation bed. The suspected Korean entered Incheon International Airport from Germany at around 4 p.m. on the 21st and reported himself suspiciously to the Korea Centers for Disease Control and Prevention and was classified as a doctor by the airport quarantine office and the central epidemiological investigator. Suspected patients are suspected of monkeypox in consideration of clinical symptoms or epidemiological associations, but there are no test results that meet the test criteria for diagnosis. The suspected patient was transferred to Incheon Medical Center for treatment after waiting for an airport quarantine facility. The quarantine authorities plan to hold a briefing as soon as the results of the Monkeypox diagnostic test and epidemiological investigation are released. In the news, President Yoon ordered the rapid distribution of vaccines and treatments and ordered the introduction of third-generation smallpox vaccines and Monkeypox treatments in Korea. President Yoon ordered, "If necessary, prepare fully so that the vaccines and treatments currently secured can be quickly distributed to the medical field and complete the introduction of additional third-generation vaccines and antiviral drugs for Monkeypox as soon as possible."
- Policy
- Abnormal cases of Inlyta in PMS for 9 yrs is 82.8%
- by Lee, Hye-Kyung Jun 24, 2022 05:45am
- As a result of a post-marketing survey of Korea Pfizer Pharmaceutical's kidney cancer treatment Inlyta, the incidence of abnormal cases was 82.88% regardless of the causal relationship. As a result of conducting PMS on 111 people over 9 years for re-examination, 92 people (338 cases in total) showed abnormal cases regardless of causality. Among them, 7.31% of the serious adverse drug reactions that cannot be excluded from the causal relationship and 14.41% of the unexpected adverse drug reactions. The MFDS announced that it plans to reflect it from September 21st after completing a preliminary notice of changes to permits according to the results of PMS. Serious drug adverse reactions in 7 out of 111 patients were pulmonary artery thrombosis, cerebral infarction, anemia, helplessness, and diarrhea. Unexpected adverse drug reactions appeared in 16 out of 111 people, and side effects such as rhinitis, gingivitis, pneumonia, edema, chest discomfort, acne, difficulty in urination, difficulty in swallowing, toothache, peripheral neuropathy, and gout appeared. Meanwhile, Inlyta was approved for domestic market on August 22, 2012. At the time of approval, it was given 6 years of re-examination for indications of progressive renal cell cancer that failed to treat one systemic therapy, but the PMS period increased to 9 years as it maintained non-reimbursement for 3 years due to delayed registration. According to the AXIS phase 3 comparing the treatment effects of Inlyta and Nexavar, the median duration of progression-free survival in the Inlyta administration group was 8.3 months, which reduced the disease progression risk by about 34% compared to 5.7 months in the Nexavar administration group.
- InterView
- Tremfya to bring generation shift in the IL inhibitor market
- by Jun 23, 2022 05:50am
- The competition among latecomers is intensifying in the interleukin inhibitor market with the scope of their indications expanding to psoriatic arthritis. The leader in this market is Janssen’s IL-12/23 inhibitor, ‘Stelara (Ustekinumab).’ Although 10 years have passed since its approval, the drug still boasts a growth rate in the 30% range. Based on IQVIA, sales of Stelara recorded ₩36.1 billion last year. Janssen’s new goal in the market is to successfully make a generation change and replace Stelara with its follow-up drug, ‘Tremfya (guselkumab),' the first-in-class IL-23 inhibitor that was released in Korea in 2018. However, Tremfya is being challenged in the market by the second IL-23 inhibitor ‘Skyrizi (risankizumab)’ that entered the market. Therefore, making the successful generational shift from Stelara to Tremfya without losing any market share to other companies’ competitors is an important task at hand for Janssen. ▲ JungHyun Lee, Tremfya Marketing Manager at Janssen Korea Janssen Korea’s Tremfya Marketing Team has been working quickly to achieve this goal. The three members of the Tremfya Team at Janssen Korea have been focusing on conducting marketing activities for the psoriatic arthritis indication that was granted insurance benefits last month. In an interview with Dailypharm, Product Manager Jung-Hyun Lee, who had been in charge of Tremfya since it started preparations for marketing authorization at the end of 2016, said, “There are many treatments including Tremfya available for plaque psoriasis, and awareness on the availability of theses drugs have now increased significantly among psoriasis patients. Just as we have concentrated on marketing Tremfya in plaque psoriasis last year, we plan to concentrate on carrying out activities to make known the importance of early diagnosis and treatment in psoriatic arthritis this year.” Lee pointed to the low disease awareness of psoriatic arthritis as the reason for this year’s specific focus of interest. PM Hye-Ji Kang who newly joined the Tremfya Marketing Team this year, said, “It is important for patients with psoriasis to manage comorbidities such as psoriatic arthritis. Therefore, we need to raise awareness of psoriatic arthritis so that doctors and patients can suspect and allow for early diagnosis and treatment of their condition when joint pain occurs while maintaining skin symptom improvement in their course of treatment.” In addition to Tremfya, the IL-17 inhibitors Cosentyx (secukinumab) and Taltz (ixekizumab) are also approved for use in psoriatic arthritis. Also, Skyrizi added a psoriatic arthritis indication in January this year. Although Skyrizi is yet to be approved for reimbursement, Janssen may not rest assured as Abbvie is speeding up its reimbursement expansion process for Skyrizi. Ultimately, it is in the hands of Tremfya’s Marketing Team to highlight the characteristics of Tremfya that differentiate the drug from other IL-17 inhibitors, while appealing to the strengths of Tremfya compared to the other same class IL-23 inhibitor. Lee said, “Inhibiting radiographic progression of joint damage is considered the most important indicator in treating psoriatic arthritis because there is no way to reverse damage in the joints. Tremfya administered every 4 weeks has demonstrated statistically significant inhibition of radiographic progression of joint structural damage compared to placebo.” Lee added, “In over 70% of the cases, psoriasis skin symptoms appear before psoriatic arthritis, and as treatment effect in the main disease of psoriasis is most important until arthritis progresses, Tremfya’s long-term effect in maintaining skin clearance indicates how our drug brings greater treatment benefit than its competitors.” The lasting long-term effect of Tremfya that was mentioned by Lee was demonstrated through a 5-year long-term clinical trial and a 5-year real-world data on domestic patients, evidencing the differentiated benefit of Tremfya over the latecomers. Another positive aspect of Tremfya is that a survey on patients with severe psoriasis in the Asia-Pacific region including Korea showed that patients consider lasting, long-term effects as most important. ▲ Hye-JeeKang, Tremfya Marketing PM at Janssen KoreaAlso, the company had demonstrated the superiority of Tremfya through a head-to-head trial. Janssen’s ECLIPSE study that directly compared the efficacy between the first-in-class IL-23 inhibitor Tremfya and the IL-17 inhibitor Cosentyx showed that Tremfya’s mechanism of action allows for psoriasis lesions to not recur and provides long-lasting improvement of skin symptoms. Kang said, “Only Tremfya was found to maintain regulatory T cells that are involved in lesion recurrence and reduce the rise of resident memory T-cells. The trial was informative in understanding the different mechanisms of action between classes. Through such data, the IL-17 and IL-23 inhibitors are being differentiated in the field, and IL-23 inhibitors, as a higher level mechanism than IL-17 inhibitors, have provided convenience to the patients with their longer dosing interval.” Of course, opposing data also exists. Novartis’ ARROW trial is one example. However, no statistically significant difference was found in the proportion of patients that achieved a “clear” or “almost clear” status of the target plaques at Week 16, which was the primary outcome measure of the trial. Kang explained, “Results from the ARROW trial show no statistical difference between the two drugs, therefore, it is difficult to say there is a difference between the two drugs based on that data. Also, the study was conducted on only 40 patients in the short term of 16 weeks, different from the large-scale ECLIPSE trial that was conducted for one year on 1,048 patients.” On how the drug is different from Skyrizi, a same-class drug, the marketing team pointed out that Tremfya is the only ‘fully human monoclonal antibody.’ In antibody drugs, reducing immunogenicity by minimizing the sequence of other species such as mice is important as it can cause side effects and reduce the efficacy of a drug. If the humanized monoclonal antibody Skyrizi has nearly a 90% human-generated nucleotide sequence, Tremfya has a 100% human-generated nucleotide sequence. Lee also added that the team will continue to strengthen Tremfya’s status in the market through the provision of various customized data. Lee said, “With most drugs now being able to provide clear skin, the needs of the patients and medical are becoming more specific and subdivided. Some wish for the occasional lesions or itching to go away after skin clearance, others wish to get rid of the pigmentation left after treatment. We will work to provide customized data to fit the needs of these patients.”
