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- 2026-03-19 00:04:23
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- Complaint on how NHIS unveiled pricing negotiation guideline
- by Eo, Yun-Ho Jul 20, 2020 06:19am
- The pharmaceutical industry in Korea is complaining on how National Health Insurance Service (NHIS) announced the drug pricing negotiation guideline. According to the industry sources, Korean Research-based Pharmaceutical Industry Association (KRPIA) has recently submitted a statement to NHIS regarding the public opinion collection procedure. At the second biannual meeting convened between NHIS and pharmaceutical industry organization on July 8, the government body has presented the detailed guideline on risk sharing agreement (RSA)-covered drug pricing negotiation, general drug pricing guideline and detailed operation guideline on price-volume agreement (PVA) negotiation. However, NHIS officials retrieved the disclosed guideline information, regardless of the organizations’ prior demand, immediately after presenting them. The participants of the meeting had to suggest limited opinions without the time to thoroughly review the guideline. And as NHIS stated the guideline would not be disclosed properly in the future, the industry organization criticized the government body for the lack of proper communication. Accordingly, KRPIA urged the government to disclose the revision for all industry entities to thoroughly review the material and to collect their opinions for further improvement in the system. In fact, the Health Insurance Review and Assessment Service (HIRA) has previously accepted the public opinion on the guideline and detailed evaluation criteria on negotiating drug for 80 days, as much as Ministry of Health and Welfare (MOHW) does for the administrative notice period. The industry source said, “The government demanding for suggestion when creating a situation without letting the industry fully understand the details is completely unfair. A guideline is practically a regulation that realizes criteria and statutes, therefore, disclosing the details to collect the public opinion is essential.” Meanwhile, the revision NHIS has unveiled included adding drug requiring negotiation or pricing calculation, fine-tuning regulations and expanding subject for RSA among drugs approved with Phase III clinical evidence development, and revising the detailed guideline on the PVA negotiation.
- Company
- Prescription performance has been recovering since June
- by Chon, Seung-Hyun Jul 20, 2020 06:19am
- The overall outpatient prescription growth in the first half of this year has slowed. It remained at the same level as last year in the aftermath of COVID-19. However, prescription performance has been recovering since June, unlike April and May. As the fear of COVID-19 spread in the first quarter, patients received prescriptions all at once and total prescription volume decreased in April and May, but it is analyzed that the prescription market has also been revitalized after the return to normal social activities. According to UBIST on the 15th, the total outpatient prescription amount in the first half of last year was ₩7.35 trillion, a 0.02% decrease from the previous year. Although the prescription performance has been growing every year, it has been slowing down this year. Rx amount & increase/decrease rate in the first half of each year (Unit: ₩100 million, %, Source: UBIST)The prescription amount in the first half of last year rose 6.9% from the previous year. In the first half of 2017 and the first half of 2018, the prescription amount increased by 5.6% and 8.1%, respectively. The prescription amount in the first quarter was ₩3,703 billion, an increase of 2.7% from the previous year. However, the prescription amount in the second quarter decreased by 2.7% to ₩3,647.4 billion. In the first and second quarters of 2019, the outpatient prescription prices rose 5.5% and 8.3%, respectively, compared to the previous year, but the prescription market was sluggish in the second quarter of this year. It is analyzed that the prescription market in 2Q was slow in the aftermath of COVID-19. It is analyzed that a large number of prescription gaps occurred in the second quarter as patients who were reluctant to visit medical institutions, especially those with chronic diseases, were prescribed large quantities of medicines at a time. It has been reported that the number of patients receiving prescriptions for 3 to 6 months in advance increased significantly when the number of COVID-19 confirmed patients increased. In addition, it is estimated that the number of visits to hospitals may have decreased as the frequency of disease occurrence among infants and children has decreased due to factors such as postponement of school, social distance, and strengthening of personal prevention of epidemics. Quarterly Rx amount trend (Unit: ₩100 million, Source: UBIST) The size of the prescription market in January was ₩1.25 trillion, a 4.4% decrease from the same period last year. However, the prescription amount in February increased by 13.0% to ₩1.21 trillion. As New Year holidays were pulled to January earlier than the previous year, the increase/decrease rate of the prescription amount in January and February was analyzed to vary. In March, the total prescription amount increased to ₩1.23 trillion, up 1.4% from the previous year, and the prescription market in the first quarter remained stable despite the spread of COVID-19. In the second quarter, the outpatient prescription amount in April was ₩1.19 trillion, a 8.7% decrease from the same period last year. In April 2018 and April 2019, the prescription amount increased 8.3% and 13.1%, respectively, compared to the same period last year, but this year it has declined. In May, the total outpatient prescription amount was ₩1.16 trillion, a decrease of 9.4% from the previous year. It fell 1.8% from April, the lowest this year. Monthly outpatient Rx amount trend (Unit: ₩100 million, Source: UBIST) It is interesting to note that the prescription market has recovered rapidly since June. The prescription scale last month was ₩1.26 trillion, 11.7% higher than last June. Prescriptions in June 2018 and 2019 rose 5.0% and 3.0%, respectively, from the previous year. It was significantly higher than the previous year despite COVID-19 outbreak. the prescription drug market in April and May was temporarily sluggish due to the fear of COVID-19 in the first quarter, and it seems to have regained growth from June. In particular, when the number of COVID-19 confirmed patients surged mainly in Daegu & Gyeongbuk, the sales activities of pharmaceutical companies also contracted significantly. Since the first COVID-19 confirmed patient in Korea on January 20, pharmaceutical companies have refrained from visiting salesmen to medical institutions. Since the middle of February, the number of COVID-19 patients has increased rapidly, and most of the pharmaceutical companies' salespeople have entered telecommuting. A significant number of patients received long-term prescriptions at one time and it is analyzed that they caused a prescription gap in April and May. The prescription drug market seems to have recovered since the spread of COVID-19 patients began to stabilize in April and social distance campaign had shifted to distancing in daily life. The size of prescription amount in the market is also estimated to have stabilized since June. In the industry, it is continually increasing due to the increase of the elderly and chronic patients. It is said that the entire industry will not contract due to short-term issues such as infectious diseases. According to the analysis, unlike the tourism and cultural industries, it is difficult to lead to a sudden recession because the pharmaceutical industry is affected by patient demand rather than the external environment.
- Company
- Rx of NOAC is recommended in COVID-19 epidemic
- by Eo, Yun-Ho Jul 17, 2020 05:55am
- NOAC products in KoreaThe need for prescription of New Oral Anti-Coagulant (NOAC) is also emerging in COVID-19 outbreak. NOAC does not require periodic INR (International Normalized Ratio) monitoring, thus reducing visits to clinics unlike Warfarin. For this reason, NOAC is a good treatment option for patients who are unable to go to the hospital or need long-term prescription due to self-isolation. At the Anticoagulation Forum (AC Forum), which consists of antithrombotic therapists around the world, Warfarin-treated patients who can convert to NOAC are recommended to switch to NOAC to minimize the risk of COVID-19 exposure because frequent hospital visits increase the risk of exposure to COVID-19. Similarly, the National Institutes of Health (NIH) published in the '2020 COVID-19 Treatment Guidelines' included the need to consider switching from Warfarin to NOAC for isolated patients, and many societies including the Royal Pharmaceutical Society in the UK have worked together to establish guidelines for the safe switching from Warfarin to NOAC in March this year. The guidelines provide detailed information, including a patient population that can switch from Warfarin to NOAC, a safe switching process, and features and checklists for each NOAC product. .An official from the Korean Heart Rhythm Society said, “I agree with the recommendation to expand the NOAC prescription in COVID-19 situation .I think NOAC is a drug that can be prescribed by clinics ."Things are different now .I think it will not be a problem if the condition of the patient, such as renal function, is checked and prescribed according to the permission,." Meanwhile, according to the '2018 KHRS Expert Consensus Recommendation for Oral Anticoagulants Choice and Appropriate Doses: Specific Situation and High Risk Patients', 'Eliquis (Apixaban, NOAC)' is first recommended for high-risk patients with advanced age, decreased renal function, and gastrointestinal bleeding .This drug has been confirmed by ARISTOTLE, a major clinical trial, to reduce the risk of stroke and systemic embolism, and to reduce the risk of major bleeding and mortality, compared to Warfarin in patients aged 75 years and older.
- Company
- Korean-made IMD Rosuzet and Zemimet prevail over COVID-19
- by An, Kyung-Jin Jul 17, 2020 05:55am
- Apparently a number of incrementally modified drugs (IMDs) developed with Korean-made technology excelled in the prescription drug market amid novel coronavirus (COVID-19) pandemic. A dyslipidemia combination drug Rosuzet and an antidiabetic combination drug Zemiglo recorded two-digit growth and settled on the top chart in the prescription drug market. On the contrary, other off-patent drugs by multinational pharmaceutical companies seemed to have stagnated in the growth. According to pharmaceutical market research firm UBIST on July 17, Pfizer Pharmaceutical Korea’s Lipitor was prescribed the most in the first half of the year, making 94.1 billion won. Although the sales fell by 0.9 percent compared to 95 billion won in last year, Liptior made more than double the sales of Daewoong Bio’s Gliatamin. Lipitor product image Lipitor, indicated to treat dyslipidemia, is an atorvastatin Pfizer Pharmaceutical Korea has launched for the Korean market in 1999. When its patent was expired, over 130 generics flooded the market, but the dyslipidemia drug has never been ranked below second place in the prescription drug market. Daewoong Bio’s cognitive enhancer Gliatamin generated total 48 billion won in the first half of the year, and came second on the rank. Compared to last year same time with 46 billion won, the drug made 4.4 percent growth. Gliatamin is a choline alfoscerate generic. Another competitor Chongkundang Gliatirin has made 39.8 billion won with 6.9 percent growth from last year, but it could not narrow the gap of 8 billion won with Gliatamin. Rosuzet (left) and Zemimet product images Among the top products, Hanmi Pharmaceutical’s Rosuzet had the highest yearly growth. Rosuzet generated 46.9 billion won in the first half of the year and leapt 24.4 percent from last year. Bascially, it was prescribed 8 billion won a month. Released in late 2015, Rosuzet is a combination drug (rosuvastatin plus ezetimibe) indicated for treatment of hyperlipidemia. Hanmi Pharmaceutical signed a deal with the ezetimibe patent owner MSD over the use of the drug, and entered the market first. The drug is dominating the same substance market among other competitors by far. The monthly Rosuzet prescription volume maintained over 10 percent growth compared to last year, regardless of the difficulties in sales and marketing caused by COVID-19. When the confirmed case of COVID-19 in Korea skyrocketed from February through March, the prescription volume growth broke through the 30-percent and 40-percent line. Continuing the current trend, the drug could generate over 100 billion won at the end of the year. Zemimet, an antidiabetic combination drug by LG Chem, also scored a high growth rate. In the first half of the year, Zemimet’s prescription surged by 18.5 percent from last year at 32 billion won to 37.9 billion won this year. LG Chem independently developed the dipeptidyl peptidase 4 (DPP-4) inhibitor by combining the novel antidiabetic treatment Zemiglo (gemigliptin) and metformin. With the co-promotion deal signed in 2016, Daewoong Pharmaceutical has been in charge of the drug’s sales. Atozet, MSD Korea’s combination drug for hyperlipidemia treatment, also demonstrated two-digit growth. The accumulated prescription volume in the first half of the year was increased by 17.5 percent from last year and generated 36.4 billion won. Atozet is a combination drug, consisting of atorvastatin and ezetimibe, which competes against Rosuzet. The drug is currently in a co-marketing deal with Chong Kun Dang since 2018. Top 20 outpatient prescription drug market in 2020 H1 (Unit: KRW 100 million) Source: UBIST Similarly to previous years, the outpatient prescription drug market in the first half of this year was vastly dominated by off-patent drugs. But their growths were underwhelming than previous years. Two hepatitis B treatments once led the prescription drug market plummeted down the rank together. Gilead Science Korea’s Viread (tenofovir disoproxil fumarate) made 43.1 billion won with a 27.3-percent plunge from last year at 59.2 billion won. This year’s prescription of BMS Pharmaceutical Korea’s hepatitis B treatment Baraclude (entecavir) marked 34.8 billion won, dipping 10.8 percent from 39 billion won last year. Eisai Korea’s cognitive enhancer Aricept (donepezil) and Astellas Pharma Korea’s benign prostatic hyperplasia (BPH) Harnal-D (tamsulosin) generated 8.0 percent and 8.2 percent less than last year, respectively. AstraZeneca’s anticancer treatment Tagrisso (osimertinib) placed itself on the top sixth spot by generating 44.7 billion won with 7.9 percent growth from last year. Tagrisso is a second-line treatment for patients with non-small cell lung cancer, who developed tolerance after administering epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) like Iressa (gefitinib), Tarceva (erlotinib) or Giotrif (afatinib). After it was listed for healthcare reimbursement in December 2017, the treatment’s prescription volume has been surging significantly. Despite the expensive treatment costing 120,000 won even for a reimbursed prescription, it is the only anticancer treatment ranked high in the outpatient prescription drug market, due to its convenience in oral administration.
- Company
- 2nd single-agent immunotherapy added for NSCLC first-line
- by Eo, Yun-Ho Jul 16, 2020 05:55am
- Another immunotherapy is expected to be added as a first-line treatment option in lung cancer. The pharmaceutical industry sources reported, Roche Korea has recently submitted an application to Korea’s Ministry of Food and Drug Safety (MFDS) to indicate programmed death-ligand 1 (PD-L1) inhibiting immunotherapy Tecentriq (atezolizumab) as a first-line treatment in non-small cell lung cancer (NSCLC). When Tecentriq’s indication expands in Korea, it would directly compete against MSD’s PD-L1 inhibitor Keytruda (pembrolizumab) in the NSCLC treatment market. Tecentriq’s efficacy as a first-line treatment in NSCLC was confirmed in a clinical trial ‘IMpower110.’ The study compared the immunotherapy against chemotherapy in treating 572 of PD-L1-selected, chemotherapy-naïve patients with Stage 4 or later NSCLC without ALK or EGFR mutations. The result found the efficacy of Tecentriq performed better than chemotherapy in patient group with PD-L1-stained in over 50 percent of tumor cells (TC), or PD-L1-statined tumor-infiltrating immune cells (IC) covering over 10 percent of tumor area. The Tecentriq administered group reached overall survival (OS) at 20.2 months, improving the figure by 7.1 months compared with chemotherapy at 13.1 months. Also for progression-free survival (PFS), the Tecentriq group (8.1 months) demonstrated better than the chemotherapy group (5 months). However, comparing the groups with TC over 1 percent but less than 50 percent, and IC over 1 percent but less than 10 percent, the improvement by Tecentriq is statistically insignificant. Accordingly, the U.S. Food and Drug Administration (FDA) has indicated Tecentriq for the first-line treatment of patients with TC over 50 percent or IC over 10 percent, and the company applied for indication expansion in Korea with the same standard. Meanwhile, Keytruda has been in a discussion with the government for over two years about extending the coverage on single and combined-agent first-line treatment in NSCLC. After the Cancer Deliberation Committee has deferred the decision last month, the coverage extension has returned to the Cancer Deliberation Subcommittee. But reportedly, the health authority and the company have not reached a clear agreement.
- Company
- Influenza vaccine inoculation rate doubled from last year
- by Jul 16, 2020 05:54am
- n the aftermath of COVID-19, the number of influenza vaccination in the National Essential Immunization Vaccine (NIP) increased significantly in the first half of this year. On the other hand, for the same reason, other essential vaccination rates are rather have declined. According to the KCDC on the 13th, the number of NIP inoculations from January to June 2020 was 5,305,373 cases. This is a 13% decrease from the same period last year. The prominent part is the flu (influenza) vaccination rate. The only number of inoculants increased. Adults and the elderly increased 234% from 4,035 cases in the first half of last year to 13,462 this year. During the same period, the number of vaccinations for children's flu also increased by 16% from 144,080 to 166,483 cases. It is analyzed that this change has a large impact on COVID-19. The industry believes that the spread of COVID-19 has increased the number of patients who are concerned about worsening respiratory immune function and are looking for a flu vaccine as a preventive measure. Data: The KCDC In particular, in the case of the flu in the 2019-2020 season, the number of inoculums increased slightly from last year due to the aftermath of COVID-19 in the second quarter, despite the release of the watch on March 27, three months earlier than last year. Another change is the NIP range of adult flu vaccination that has expanded since the third quarter of last year. The government has added a pregnant woman to the adult flu vaccine NIP since September of last year. However, the vaccination rate of the vaccines excluding the flu fell significantly. The vaccination rate of BCG (tuberculosis) vaccine fell 41% year-on-year, and the MMR (measles, mumps, rubella) vaccine also decreased by 35%. The number of MMR vaccines in the first half of last year was 553,875 cases, but this year only 359,022 cases. In the same period, the vaccination rate of the IPV (poliomyelitis) vaccine also decreased by 31% from 101,225 to 69,999 cases. The pneumococcal vaccination rate targeting people over 65 also decreased by 17%, raising concerns that vaccination is urgent. Pneumococcus is one of the leading causes of pneumonia, especially fatal in the elderly. The KCDC focused on emphasizing pneumococcal immunization by expanding the number of inoculation institutions to private hospitals and clinics (designated medical institutions), fearing that the utilization rate of the intensive care unit in COVID-19 outbreak will increase due to the occurrence of serious ill patients due to pneumococcal infections and complications. In addition to this, vaccination rates, such as Japanese encephalitis vaccines (inactivated vaccines·live attenuated vaccine), hepatitis A (HepA), hepatitis B, and pneumococcal (PCV), all decreased, except for the human papillomavirus (HPV) vaccine. The KCDC urged the mandatory immunization to be immunized, saying, "If the immunization is delayed or discontinued, it may be necessary to respond to the epidemic of infectious diseases targeted for immunization such as measles in addition to COVID-19 response by the end of 2020."
- Company
- "Ezetimibe combination drug, now key option in dyslipidemia"
- by Eo, Yun-Ho Jul 15, 2020 06:33am
- Professor Heo Jung Ho Statin has been demonstrating outstanding efficacy in low-density lipoprotein cholesterol (LDL-C) level control, while showing an assuring benefit in risk of cardiovascular death. The medicine has surely shifted the paradigm of dyslipidemia management. Nevertheless, there is no perfect drug in this world. Statin also has concerning reports of risk of diabetes and musculoskeletal adverse reactions when using high-dose (high-intensity). Still, the ‘statin plus ezetimibe’ combination is well sought after in the market. Following the current trend in cardiovascular disease treatment—the lower the LDL-C, the better for the benefit in cardiovascular system—the combination drug has taken up a significant share of the pie in dyslipidemia treatment prescription. Even in Korea, many pharmaceutical companies have combined ezetimibe with atorvastatin or rosuvastatin to launch combination drugs. The released drugs have now settled in the market. Daily Pharm interviewed Professor Heo Jung Ho of cardiology division at Kosin University Gospel Hospital to hear about his opinion on the ezetimibe and its efficacy. -Generally, when is ezetimibe combination therapy used? Personally, I still follow the pattern of initiating the prescription from moderate to high-dose statin through high-dose statin. But in some cases, patients cannot reach the recommended LDL-C target level at 70 mg/ dL (Korean guideline), or 55 mg/ dL (U.S. guideline), even with high-dose statin. And this is when I use the ezetimibe combination drug. And for patients seeing musculoskeletal adverse reaction or having high risk in diabetes, the ezetimibe combination therapy could be a good option. -What is your opinion on using the ezetimibe combination therapy as a first-line treatment for dyslipidemia patients? A clinical study in Korea is in process to confirm clear evidences. Currently, Professor Jang Yangsoo at Yonsei University Severance Hospital is leading the head-to-head comparative trial of high-intensity statin and ezetimibe combination therapy in over 3,000 patients with cardiovascular disease in Korea. 200 of the participating patients are registered from Kosin University Hospital. The outcome of the study to be disclosed in three years would give us some clearer answers. Personally, I expect both of the groups would demonstrate clinically meaningful result and efficacy. -Between rosuvastatin and atorvasutatin, what are some circumstances to be considered when prescribing a combination therapy? There is no big difference between the two. But some patients prefer either ‘atorvastatin plus ezetimibe’ or ‘rosuvastatin plus ezetimibe.’ In such case, I base my decision on clinical evidences. The effects of 20 mg of rosuvastatin and 40 mg of atrovasutatin are on par, but the combination that noticeably lowers LDL-C level would be used. -Do you prefer to use a combination drug for ezetimibe combination therapy? First of all, the combination drug is obviously more convenient. The medication convenience along with adherence is high. Patients these days ask many questions and research more information online when the number of drugs goes up. A combination drug is easy to explain how the effect is better with the same amount of drugs, and the patients also comply with the medication well. Moreover, the price of combination drug in Korea is comparatively lower against in other countries. As chronic disease patients are sensitive to the cost, the healthcare system in Korea has also boosted the preference in combination drug. - The Korean dyslipidemia treatment guideline recommends ezetimibe therapy as a second-line therapy. Although the U.S. and Europe recommends LDL-C level in the said ultra high risk group to be lowered to 55 mg/ dL and 40 mg/ dL, respectively, Korea recommends the level to be lowered to 70 mg/ dL. The bottom line is that I agree with the slogan of ‘the lower LDL-C is the better.’ However, it is not the absolute rule to be followed. I personally treat patients targeting LDL-C level at 70 mg/ dL at the moment. But when the patients show risk factors like acute coronary syndrome (ACS), myocardial infarction (MI) or peripheral artery disease (PAD), the target level is lowered to 55 mg/ dL. These patients should be more aggressive in lowering the LDL-C level. And if their level does not respond with ezetimibe, Proprotein convertase subtilisin/ kexin type 9 (PCSK-9) inhibitor is prescribed to breakthrough. According to the healthcare reimbursement standard, ezetimibe has to be prescribed as prerequisite. And this is one of the factors raising the prescription rate of combination drug.
- Company
- Zepzelca by Boryung designated as an orphan Drug
- by An, Kyung-Jin Jul 15, 2020 06:33am
- ZepzelcaBoryung announced on the 13th that it is in the process of receiving a new drug called small-cell lung cancer (SCLC) 'Zepzelca' (Lurbinectedin) as an orphan drug. Zepzelca is an anticancer drug that Boryung has exclusive rights to domestic development and sales. In 2017, Boryung signed a technology introduction contract with PharmaMar in Spain. Since Lurbinectedin obtained a sales license from the FDA last month, it is adjusting the timing of its introduction in Korea. It is confirmed that the application of an orphan drug has been recently submitted to the MFDS and the supplementary documents have been submitted. The indication that Zepzelca has been approved for this time is for adult patients with metastatic small cell lung cancer whose disease has progressed since platinum chemotherapy. The FDA made a rapid approval decision based on data from phase II clinical trials that proved superiority in terms of safety and effectiveness through indirect comparison with the existing treatment, Topotecan. The condition is that additional phase III clinical trial data must be submitted to remain approved. Small cell lung cancer is one of the most aggressive types of lung cancer. It has been known to cause metastasis from the early stages and a high recurrence rate after treatment. Anti-cancer drugs currently approved in Korea for secondary treatment for small cell lung cancer include Novartis Korea's 'Hycamtin' (Topotecan) and Chong Kun Dang's 'Camtobell' (Belotecan). Boryung plans to apply for phase III conditional domestic permit application in the same way as the United States when the designation of an orphan drug of Zepzelca is completed. It is expected that the acquisition of a domestic license will be a new treatment option in the field of recurrent small cell lung cancer. Kim Yeong-seok, chief of anticancer drugs at Boryung said, "Small cell lung cancer is a disease with poor prognosis and limited treatment options, but if Lurbinectedin is quickly approved through the designation of an orphan drug, it is expected to provide new treatment options to domestic patients and medical staff."
- Company
- Xofluza efficacy confirmed in household transmission
- by Eo, Yun-Ho Jul 14, 2020 06:12am
- A next-generation flu drug Xofluxa’s effect of preventing flu virus transmission among the patient’s household member has been confirmed. The latest edition of New England Journal of Medicine (NEJM) published on July 8 reported the clinical findings of Xofluza (baloxavir marboxil) and its flu preventive effect. The study evaluated the flu drug’s positive post-exposure prophylaxis efficacy on household contacts by administrating Xofluza. The outcomes of post-exposure prophylactic efficacy of the drug were confirmed based on household contacts of confirmed flu patients during the 2018–2019 flu season. After identifying the index patients confirmed with influenza of their households from November 2018 through March 2019, the researchers conducted a positive rapid flu diagnostic test on the patients and administered either Xofluza or neuraminidase inhibitor as an antiviral treatment. Based on the clinical trial participants consisting of 545 influenza patients and 752 household contacts, the study screened them twice-daily for axillary temperature until day 10 since the initial influenza diagnostic test and had at least 12-year-old participants self-monitor their influenza symptoms. 95.6 percent of the participants were tested positive for influenza A, 73.6 percent were younger than 12, and 52.7 percent were administered Xofluza. Major adverse reactions in patients over age 12, such as cough and sore throat, headache, nasal discharge or congestion, feverishness or chills, muscle or joint pain, and fatigue were noted. In the age group under 12, different levels of severity was scored by identifying symptoms like cough and nasal discharge or congestion. Participants developing moderate to severe level of flu-like symptoms like fever were instructed to visit respective clinical institutes and provide their samples with nasopharyngeal swabs. The obtained sample was processed with reverse-transcriptase-polymerase-chain-reaction (RT-PCR) analysis to confirm influenza virus, virus type and subtype. The study’s primary efficacy endpoint was the laboratory-confirmed clinical flu, and the secondary endpoint were a ratio of RT-PCR-confirmed viral infection regardless of fever of flu-like symptoms against RT-PCR-confirmed patients with body temperature of at least 37 degrees Celsius or demonstrating at least one moderate or severe symptom. Analyzing Xofluza group of 374 participants and placebo group of 375 participants, the ratio of patients developing clinically-confirmed influenza was lower in Xofluza group against the placebo group. The outcome was noticeably contrasting between 1.9 percent in the Xofluza group and 13.6 percent in the placebo group. The efficacy was also apparent in subgroup analysis in unvaccinated, high-risk and pediatric groups. In the Xofluza group, regardless of symptoms, the influenza risk was measured 57 percent lower. Moreover, the risk of adverse reaction in both groups of Xofluza and placebo did not show significant difference at 22.2 percent and 20.5 percent, respectively. Xofluza is a next-generation influenza drug Roche released after commercializing Tamiflu two decades ago. The new endonuclease-inhibiting flu drug is highly anticipated by the market as it can treat influenza by one-dose oral administration (Tamiflu administered for five days).
- Company
- 14 new drugs approved from Jan to June with no Korean drug
- by Jul 14, 2020 06:12am
- Korea’s Ministry of Food and Drug Safety (MFDS) reported total 14 new drugs have been approved from Jan 1 to June 30 this year. While none of them were a Korean-made, the absence of Korean-made new drug has continued for two years now. Pfizer Pharmaceutical Korea, Astellas Pharma Korea and Bayer Korea received the highest number of new drug approvals with two products each, and Eisai Korea, Novartis Korea, AbbVie Korea, Bayer Korea, Roche Korea, Menarini Korea, MSD Korea, Daiichi Sankyo Korea and Handok respectively received one new drug approval as well. Source: Ministry of Food and Drug Safety Categorized by each month, January had the highest number of new drug approvals at four. From February to June, one, two, one, three and three new drugs were approved, respectively. By disease type, anticancer treatments (five products) had the highest number of approvals, and Janus kinase (JAK) inhibitors treating rheumatoid arthritis with two approvals came second. Early this year, Daiichi Sankyo’s peripheral neuropathic pain treatment Tarlige and Astellas Pharma’s rheumatoid arthritis treatment Smyraf were the first ones to receive approval. Pfizer Pharmaceutical’s antifungal Cresemba and MSD’s human immunodeficiency virus (HIV) treating combination drug Delstrigo followed the next. On Feb. 14, Pfizer Pharmaceutical won the health authority’s approval on second generation non-small cell lung cancer targeted therapy Vizimpro. In March, Xospata, a FMS-like tyrosine kinase 3 (FLT3) inhibitor indicated to treat acute myeloid leukemia by Astellas Pharma, and Ranexa, a novel angina treatment by Menarini were approved. In April, the Korean government green lit Roche’s anticancer treatment Rozlytrek that targets all solid tumors with neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Three new drugs were cleared in May—Handok’s paroxysmal nocturnal hemoglobinuria (PNH) treatment Ultomiris and Bayer’s two anticancer treatments (Nubeqa and Vitrakvi). Nubeqa is an oral androgen receptor inhibitor (ARi) indicated to treat non metastatic castration resistant prostate cancer (nmCRPC), and Vitrakvi is orally taken selective tropomyosin receptor kinase (TRK) inhibitor for targeted therapy. In June, AbbVie’s rheumatoid arthritis treatment Rinvoq, Novartis’ macular degeneration treatment Beovu and Eisai’s Parkinson’s disease treatment Equifina were approved in the order. Including Novartis’ Lutathera approved on July 9, the Korean health authority has cleared 15 new drugs so far this year. No Korean-made drug approved for two years, but expecting one within this year Continuing on from last year, none of the approved drugs were made in Korea this year. Although Handok owns the license over Ultomiris, the drug was originally developed by the U.S.-based company, Alexion. Similarly, all drugs sought after approval last year by Korean companies were licensed from other global companies. HK inno.N’s (formerly CJ Healthcare) potassium competitive acid blocker (P-CAB) K-CAB approved on July 5, 2018, was the last Korean-made drug. As an osteoarthritis gene therapy Invossa’s license was revoked in 2019 and Dong-A ST withdrew licenses on two types of Sivextro, three out of total 31 Korean-made drugs were removed from the market. Finally, however, a long-awaited new Korean-made drug is expected to get approved. Daewoong Pharmaceutical is seeking for an approval on its P-CAB Fexuprazan and the application has been submitted last November. Considering the review process takes approximately ten to 12 months until the final decision, the drug is expected to get passed within this year. But the novel coronavirus (COVID-19) delaying the approval review process could bring unexpected change to the estimated approval date.
