- LOGIN
- MemberShip
- 2025-12-26 15:39:16
- Company
- Keytruda annual sales top the market for the first time
- by Chon, Seung-Hyun Feb 24, 2021 06:02am
- An immunotherapy Keytruda has topped the South Korean pharmaceutical market for the first time. Its outstanding effect confirmed in treating various cancer types have generated sales profit to dominate the market. Anticancer treatment Tagrisso and immunotherapy Humira surpassed the annual sales of 100 billion won. A pneumococcal pneumonia vaccine Prevnar 13 had its sales soaring amid the novel coronavirus infection (COVID-19) outbreak. According to the pharmaceutical market research firm IQVIA on Feb. 21, MSD marked the highest sales last year with Keytruda making 155.7 billion won. Keytruda pushed aside Lipitor and took over the first place making year-on-year growth of 24.8 percent. It is first time for Keytruda took the market leadership for the time since its launch in 2015. Immediately after the market release, Keytruda’s annual sales have remained around 10 billion won in 2016 and 2017, but the figure grew rapidly and hit 70 billion won in 2018. The demand on the drug has surged as the healthcare insurance coverage was granted from August 2017 as a second-line therapy treating non-small cell lung cancer (NSCLC). Keytruda sales in 2019 exceeded 100 billion won, and it was also the drug with highest sales revenue last year. Keytruda is an immune checkpoint inhibitor that blocks PD-L1 receptor from biding with PD-1 pathway on the surface of T-cell and activates immune cells to treat the tumor cells. The drug showed notable efficacy in treating over 30 cancer types including melanoma, lung cancer, head and neck cancer, stomach cancer and cervical cancer. The vastly wide range of indication eventually helped the drug to boost the sales. Moreover, the sales in AstraZeneca’s Tagrisso rapidly grew as well. Compared to the year before, Tagrisso last year grew by 34.5 percent and made 106.5 billion won. Approved for sales in South Korea in 2016, Tagrisso is a second-line treatment prescribed to NSCLC patients who developed tolerance in EGFR tyrosine kinase inhibitors (TKIs) like Iressa, Tarceva and Giotrif. The medicine is considered a third-generation treatment that overcame EGFR-TKI tolerance. After receiving the healthcare reimbursement from December 2017, the drug sales have been growing consistently in South Korea, where it exceeded over 100 billion won a year in just four years into the market. AbbVie’s autoimmune disease treatment Humira grew by 8.1 percent from the year before making 104.2 billion won last year, and exceeded the 100 billion won-line for the first time. A tumor necrosis factor-alfa (TNF-α) inhibitor Humira has the most number of indications among TNF-α inhibitors with 14 indications. Targeting such diverse patient group with the range of indications, the drug was able to maintain the high growth. In 2020, Keytruda, Lipitor, Avastin, Tagrisso and Humira were the five drugs that broke through the 100 billion won-line. All were developed by multinational pharmaceutical companies. Although Lipitor sales dipped by 4.9 percent and handed over the top place to Keytruda, it still made over 100 billion won and consolidated its strong presence in the market. Pfizer’s pneumococcal pneumonia vaccine Prevnar 13 generated 81.3 billion won last year and showed off an exceptional year-on-year growth of 64.8 percent. Prevnar 13 is a pneumococcal conjugate vaccine (PCV13) that prevents infection from 13 types of pneumococcal pneumonia (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). The vaccine can be inoculated to all age group older than 6-week-old. Chong Kun Dang is in charge of distributing the vaccine for adult in South Korea, whereas the infant and children vaccine distribution is handled by Korea Vaccine. The market research firm analyzes Prevenar 13 has been showing consistent growth in sales over the years from 2016 through 2019 making 56.1 billion won, 49.1 billion won, 50.5 billion won and 49.4 billion won, respectively, but last year’s sales soared abruptly amid COVID-19. They evaluate the use of the vaccine in adults has leapt sharply as many were convinced by a number of experts claiming the vaccine can weakened the pneumonia symptoms induced from COVID-19, although it cannot prevent the pneumonia itself. Amgen’s osteoporosis treatment Prolia joined the top ten by making 75.1 billion won last year showing year-on-year growth of 58.6 percent. Released to the South Korean market in November 2016, Prolia is a biologic osteoporosis treatment directed against receptor activator of nuclear factor-κB ligand (RANKL), which interferes with the formation, activation, and survival of osteoclasts. The drug’s sales started taking off since it was listed for reimbursement in 2017 as a second-line treatment. And Prolia’s sales grew exponentially from 3.7 billion won in 2017 to 14.3 billion won in 2018. Also when it successfully expanded the reimbursement as a first-line treatment from April last year, the figure hit 47.3 billion won and it continued to soar last year as well. Experts point out the sales partnership with Chong Kun Dang has strengthened the growth. Meanwhile, none of South Korean companies had their product in the top ten. The influenza vaccines developed by GC Pharma and SK Bioscience both remarkably made 40 billion won each in last year’s fourth quarter. However, in last year as a whole, they respectively made 63.8 billion won and 51.5 billion won, and failed to list their names on the leader board.
- Company
- Market sales of Saxenda & Qsymia are the highest ever
- by An, Kyung-Jin Feb 23, 2021 06:11am
- Despite COVID-19 incident last year, the domestic obesity treatment market set a new record. the market sales of Qsymia and Saxenda, which is known for injectables to lose weight, expanded to the highest level ever. According to IQVIA on the 23rd, the domestic market for obesity treatments last year was ₩143 billion. It has achieved the largest scale ever, increasing 6.6% from the previous year. Compared to ₩96.8 billion in 2018, this is an increase of 47.7% in two years. Belviq (Lorcaserin), which had formed annual sales of ₩10 billion, was withdrawn due to safety issues at the end of 2019 and suffered a global recession due to COVID-19, but it recorded a new record in sales for the third consecutive year. NovoNordisk's Saxenda and Alvogen Korea's Qsymia led the expansion of obesity treatments. Last year, Saxenda recorded sales of ₩36.8 billion. Although it decreased by 13.6% from the previous year, the sales volume is the largest among obesity treatment drugs on the market. The market share based on accumulated sales last year was 25.7%, maintaining a gap of about 10%p. Saxenda is the world's first obesity treatment approved as an analogue of GLP-1 (Glucagon-Like Peptide 1). It is the same as Victoza (Liraglutide), which is prescribed for type 2 diabetics. It has enjoyed a boom over the past two years as a perception that it is relatively safe because it acts as the same mechanism as GLP-1 in the human body to suppress appetite and induce weight loss. Saxenda ranked first in sales of obesity drugs in the fourth quarter of 2018, the first year of its release, with sales of ₩5.6 billion. In the first quarter of 2019, it set a record of ₩10.5 billion in sales and ₩11.9 billion in sales in the third quarter of the same year. At that time, the market share of Saxenda reached 33.7%. Qsymia was released in the first quarter of last year with sales of ₩4.3 billion, and at the same time, it ranked second in sales of obesity drugs. Since then, sales rose sharply to ₩5.8 billion in the second quarter and ₩6.5 billion in the third quarter. Last year's cumulative sales of Qsymia were ₩22.5 billion, and the market share was 15.7%. In the fourth quarter of last year, the quarterly sales of both Saxenda and Qsymia decreased slightly, but the proportion of the total obesity treatment market accounted for 41.5% of the total sales among the 110 products. Qsymia is a combination of Phentermine/Topiramate, which Alvogen Korea obtained domestic copyright from Vivus in the United States in 2017. Alvogen Korea signed a joint sales contract with Chong Kun Dang at the end of 2019 and began marketing in earnest from the beginning of last year. The sales power of Chong Kun Dang and Alvogen Korea, which has the know-how to sell obesity drugs such as Furing and Furimin, created a synergy. Although Belviq was withdrawn, Qsymia, which contains relatively low psychotropic ingredient and can be prescribed for a long period of time, was released even though it is an oral drug. It is an analysis that it was able to continue unprecedented success in the obesity treatment market. Except for Saxenda and Qsymia, sales of other products were sluggish last year. Last year's sales of Daewoong's Dietamin were ₩9.2 billion, down 3.2% from the previous year. Until the fourth quarter of 2019, it was the second most-selling item after Saxenda, but sales decreased with the release of Qsymia. Huons' Hutermin (₩6.1 billion) and Alvogen Korea's Furing (₩5.1 billion) also decreased by 1.6% and 3.8% compared to the previous year's sales. It is observed that NovoNordisk, which has successfully developed generics, has not yet decided to release it in Korea and that competition between Saxenda and Qsymia will continue for the time being.
- Company
- Gilead on its way to introduce HCV drug Epclusa in Korea
- by Eo, Yun-Ho Feb 23, 2021 06:11am
- Gilead is finally showcasing another pipeline for hepatitis C virus infection. The pharmaceutical industry source reported Gilead Science Korea has submitted an application for the South Korean health authority’s approval on a pan-genotype hepatitis C virus (HCV) infection treatment Epclusa (sofosbuvir/velpatasvir) to be used on an adult patient with chronic HCV infection, regardless of liver cirrhosis. Epclusa is a fixed-dose combination drug consisting of 400 mg of Sovaldi (sofosbuvir), authorized by the U.S. Food and Drug Administration (FDA) in 2013, and 100 mg of a nonstructural protein 5A (NS5A) inhibitor velpatasvir. The combination drug can be administered once-daily in combination with ribavirin for patients with moderate to severe decompensated liver cirrhosis patients. Even without interferon, 12-week treatment of the drug can show close to 90 percent response rate. Three of ASTRAL clinical trials conducted with 1,558 patients with all six hepatitis C genotypes without cirrhosis or with compensated cirrhosis found 95 percent to 99 percent of patients using Epclusa achieved sustained virologic response at week 12 (SVR12). 87 patients with moderate to severe HCV infection in the ASTRAL-4 trial reached a high SVR12 rate of 94 percent, while the most common adverse reactions were headache and fatigue. Although the treatment for genotype 2 and 3 HCV infection used to be complicated, now Epclusacan be used regardless any genotype, as does AbbVie’s Mavyret (glecaprevir/pibrentasvir). The focus of HCV infection treatment seems to leaning towards pan-genotype treatment. The World Health Organization’s (WHO) latest HCV infection treatment guideline recommends using pan-genotype treatment like Mavyret, which does not require further examination.
- Company
- Competition between Soliris & Enspryng is predicted in Korea
- by Eo, Yun-Ho Feb 23, 2021 06:11am
- Competition between two expensive drugs is expected in the field of Neuromyelitis Optica Spectrum Disorder Aggravate (NMOSD) According to related industries, Roche's Enspryng (Satralizumab) is in the process of domestic approval, while Handok's Soliris (Eculizumab) recently added an indication for optic neuromyelitis. Soliris has been used only as a treatment for paroxysmal nocturnal hemoglobinuria (PNH), but the indication has been expanded. Enspryng is currently competing with Soliris in the United States, and is attracting attention because It is attracting attention because it is cheaper than Soliris. Alexion, developer of Soliris, added an indication for NMOSD in the United States last June. However, it is not known how long it will take for both drugs to apply insurance benefits. Neuromyelitis Optica Spectrum Disorder (NMOSD) is a rare relapsing autoimmune disorder that preferentially causes inflammation in the optic nerve and spinal cord. Since there is no clear treatment so far, high-dose steroids are generally used, and immunoglobulins, a blood product, are administered to severely ill patients, or plasma separation is performed. Soliris demonstrated efficacy in preventing the risk of relapse of optic neuromyelitis. 97.9 percent of patients receiving Soliris were relapse-free at 48 weeks compared with 63.2 percent of patients receiving placebo. New data published in NEJM and to be presented for the first time at the AAN meeting confirm that the significant relapse reduction observed in the PREVENT study was sustained through three years of treatment. This approval is supported by results from two randomized controlled Phase III clinical trials, the SAkuraStar and SAkuraSky studies, in which Enspryng demonstrated robust and sustained efficacy and a favorable safety profile in adults with AQP4 antibody positive NMOSD. In the SAkuraStar monotherapy study’s AQP4 antibody positive subgroup, 76.5% of Enspryng-treated patients were relapse-free at 96 weeks, compared to 41.1% with placebo. In the SAkuraSky study, which evaluated Enspryng when used concurrently with baseline IST, 91.1% of Enspryng-treated AQP4 antibody positive subgroup patients were relapse-free at 96 weeks, compared to 56.8% with placebo.
- Company
- Dupixent to treat pediatric patients with atopic dermatitis
- by Eo, Yun-Ho Feb 22, 2021 06:17am
- The use of atopic dermatitis and asthma treatment Dupixent (dupilumab) could be expanding also in South Korea to be administered to children. A pharmaceutical industry source reported Sanofi Genzyme has submitted an indication expansion application last year on Dupixent to be indicated for a ‘treatment in pediatric patients aged six through 11 with severe case of atopic dermatitis and underlying condition of various type 2 inflammations,’ and a ‘treatment in patients with type 2 inflammatory asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).’ The approval decision would be made within the first quarter of the year. A Phase III trial has reportedly confirmed the efficacy of Dupixent and topical corticosteroids (TCS) combination therapy in treating pediatric patients with atopic dermatitis. The trial found the Dupixent combination group showed average 82 percent improvement from baseline in disease extent and severity, when administered every four weeks, compared to 49 percent improvement in placebo group. Also for other indicators like skin itchiness and clearance, the combination therapy performed improved efficacy compared against TCS alone. Even if the health authority approves of the additional indications, it is unclear how long it would take to expand the National Health Insurance (NHI) coverage. Dupixent was authorized for sales in South Korea in March 2018, and it was listed for NHI reimbursement in January 2020 after submitting the application in February 2019. Expanding the indication for pediatric patient would increase the usage significantly that the health authority and the applicant company would have to reach a difficult agreement for the coverage expansion. Since January 2021, Dupixent was applied with a special case coverage for treating severe level of atopic dermatitis, bringing down the patient copayment rate from 60 percent to 10 percent. Up until then patients paid about 12 million won for administering 27 doses per year at a tertiary hospital, but now with the special case coverage, the patients would only have to pay 2 million won annually.
- Company
- Talks on expanding coverage on Tecentriq to start soon
- by Eo, Yun-Ho Feb 19, 2021 06:17am
- An immunotherapy Tecentriq (atezolizumab) is to face the first threshold to expand the National Health Insurance (NHI) reimbursement in treating patients with either triple-negative breast cancer (TNBC) or hepatocellular carcinoma. A pharmaceutical industry source reported the Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee would be convened on Feb. 24 to deliberate Roche Korea’s programmed death-ligand 1 (PD-L1) inhibiting immunotherapy Tecentriq seeking to expand reimbursement on indication to treat patients with TNBC and hepatocellular carcinoma. Last year, Tecentriq, in combination with nanoparticle albumin-bound (nab) paclitaxel, won the South Korean health authority’s approval to treat patients with TNBC as a first-line treatment, and it also earned an approval to treat liver cancer as a first-line treatment through Avastin (bevacizumab) combination therapy. Once it successfully expands its coverage, Tecentriq would be the first immunotherapy option for the two cancer types. However, it is still unknown what decision the Cancer Deliberation Committee would make. Tecentriq’s first reimbursed indication, treating patients with non-small cell lung cancer (NSCLC) as a second-line treatment, was approved by the South Korean government as the company accepted the condition to cover the initial administration cost. However, Roche has not commented if it would take the same condition for the expanded coverage. The two indications barely had any treatment option and an emerging option of an immunotherapy heightened the interest of medical academics. As far as the possibility goes, the TNBC indication would be more likely. Only 12 percent of patients diagnosed with breast cancer are specifically diagnosed with TNBC, and only a half of the particular patient group would consider Tecentriq option (PD-L1 expression rate is over 1 percent). Relatively small patient size would cause less financial burden. Moreover, TNBC is mostly diagnosed in young and socially active patients younger than 40, which causes high socioeconomic cost from faltering labor, productivity and childcare activities. Accordingly, the coverage on Tecentriq combination therapy could favorably contribute in reducing the social cost in long term. To this date, the needs for the treatment in patients specifically with TNBC—reacting negatively on all receptors (estrogen, progesterone and HER2)—have been unmet. In the IMpassion130 trial, the combination of Tecentriq and nab-paclitaxel demonstrated median progression free survival (mPFS) of 7.5 months in first-line treatment of patients with PD-L1 positive metastatic TNBC, and lowered the risk of progression or death by 40 percent compared with nab-paclitaxel alone. In the same patient group, the Tecentriq combination therapy achieved the median overall survival (mOS) at 25.0 months. Professor Im Seock-ah at the oncology department of Seoul National University Hospital said, “The Tecentriq combination therapy demonstrated a meaningful improvement in PFS and mOS longer than two years in patients with metastatic TNBC. We can anticipate the treatment option to be a crucial turning point in treating metastatic TNBC with high unmet medical needs.” Meanwhile, the efficacy of Avastin combination therapy treating patients with hepatocellular carcinoma was confirmed in the IMbrave150 study. The result found the patient group using Tecentriq in combination with Avastin reduced the risk of disease worsening or death by 41 percent, compared with Nexavar (sorafenib) patient group. The Tecentriq plus Avastin therapy was also confirmed superior than Nexavar therapy as the combination therapy group’s mPFS marked 6.8 months, which was significantly longer than Nexavar group’s 4.3 months. The combination therapy has not reached the mOS, but the median value during the monitoring phase was at 8.6 months. Nexavar had mOS of 13.2 months. Also the combination therapy’s response rate at 27 percent doubled Nexavar therapy’s at 12 percent. Professor Kim Doyoung of Gastroenterology Department at Severance Hospital noted, “Beside the OS, the improvements in the response rate and PFS were positive findings. We are glad to have found an immunotherapy option in the liver cancer area that has no other alternative than Nexavar. Hopefully, the drug can meet the highly unmet medical needs in the future.”
- Company
- Meditoxin and Innotox back for sales, but what about safety?
- by Feb 19, 2021 06:17am
- Although the Ministry of Food and Drug Safety (MFDS) ordered a license revocation on Medytox’ botulinum toxin drugs, they would be back on the shelf and available for sales as the court halts the administrative action. The relevant industry insiders are pointing out MFDS should be more thorough with pre-sales lot release approval for the people’s health and safety. In late 2019, MFDS ordered the company to shorten the expiration date due to safety issues, and imposed an item approval revocation on Meditoxin in June 2020, when it was found to have used unapproved ingredient and manipulated submitted national lot release review material. The ministry also revoked the license on a liquid type botulinum toxin Innotox in last January, because of safety validation evidence. But regardless of the order, Medytox can still sell these drugs now. The court accepted the company’s request for the administrative order suspension. The Daejeon District Court halted the administrative order until the 30th day from the day the decision is made. A biologic drug, botulinum toxin has to receive MFDS’ national lot release approval before selling. The approval is reviewed to ensure safety and efficacy in each lot of the biologic drug, which should be strictly managed to avoid contamination. As the national lot release review is conducted immediately after manufacturing and before distributed to the market, the review cannot ensure the product’s safety exposed to a risk during the destruction process. Especially if the safety evidence was manipulated, the product’s safety cannot be ensured until which point, and consumers would be clueless as to when the product to be administered to a patient is manufactured. A pharmaceutical and bio industry insider expressed concern and commented, “The court reportedly decided to suspend the administrative order to prevent the company from unrecoverable damage. But if the product, before fixing its safety issue, gets distributed, unexpected adverse reaction could happen.” Also there is an issue of fairness. Kolon Life Science’ Invossa had its license revoked due to suspected evidence manipulation, and the court refused to accept the company’s request to suspend the administrative order due to potential risk in safety. Since the Invossa incident, MFDS firmly stated there would be no tolerance for such evidence manipulation, and the ministry reconsolidated the principle with Meditoxin incident. Another industry insider noted, “The court’s decision to suspend the administrative order does not assure safety. MFDS needs to stringently review products to meet the objective of the national lot release review and to assure safety in the people.”
- Company
- 19 Korean companies to challenge Entresto patent
- by Kim, Jin-Gu Feb 18, 2021 06:25am
- A series of South Korean pharmaceutical companies are challenging the patents on Novartis’ heart medicine Entresto (sacubitril, valsartan plus sodium salt hydrate complex). Starting with Elyson Pharm filing a patent trial as a first in last year, 18 other companies expressed their intention to release their generics early. According to a pharmaceutical industry source on Feb. 16, South Korean pharmaceutical companies like CTC Bio, Boryung Pharmaceutical, Yuyu Pharma, Corepharm Bio, Kyperion, MFC, Sinil Pharmaceutical, Daewon Pharmaceutical, Yooyoung Pharmaceutical, Hana Pharm, Hanlim Pharm, Ahn-gook Pharm, Hanmi Pharmaceutical, Chong Gun Dang, Daewoong Pharmaceutical, Genuonesciences, Samjin Pharmaceutical and Kolmar Pharma submitted a patent trial request from Feb. 9 through 15 and joined the race to challenge Entresto patent. Same as Elyson Pharm that started the process earlier, the group of South Korean pharmaceutical companies have filed a negative scope confirmation on Entresto’s crystalline form patent. Currently, total four patents are listed under Entresto brand. Aside from the crystalline form patent to be expired on Sept. 21, 2027, the drug has a product patent expiring in July 2027 and two composition patents expiring January 2029. For an early release of the Entresto generic, the group of South Korean companies would have to also overcome other outstanding patents. By successfully evading the four patents, the follow-on drug companies would be able to launch their generics after April 13, 2022, when the original drug’s post-marketing surveillance (PMS) ends. Norvatis released Entresto, a hard-to-treat heart failure drug, in the South Korean market in October 2017. In the first year of launch in 2018, the drug generated 6.3 billion won from outpatient prescription, and the sales tripled in just two years in last year making 20.3 billion won. South Korean companies have been highly interested in such profitable market for their Entresto generics. Some companies have reportedly initiated bioequivalence test. A pharmaceutical industry associate told, “As Elyson Pharm challenged Entresto patent first, other companies planning to release generics early are also trying to overcome the patent.”
- Company
- SK Bioscience has signed a technology transfer contract
- by Kim, Jin-Gu Feb 18, 2021 06:24am
- SK Bioscience has secured the right to independently produce it in Korea by transferring the technology of Novavax vaccine. SK Bioscience announced on the 16th that it has licensed NVX-CoV2373 and signed a contract with the KCDA to supply 40 million doses of vaccine respectively. SK Bioscience announced on the 16th that it has signed a technology transfer (License In) contract with Novavax for COVID-19 vaccine NVX-CoV2373, and 40 million dose vaccine supply contract with the KCDA. SK Bioscience signed a CDMO (Contract Development & Manufacturing Orgainzation) contract with Novavax in August last year. Since then, it has completed the transfer of vaccine manufacturing and process technology and is conducting commercial production for global supply. It is expected that the domestic supply through this contract will be able to start production immediately. Novavax vaccine uses a synthetic coronavirus spike protein to teach the immune system to produce antibodies that can deactivate the coronavirus. It has proven its long-term safety and effectiveness by being used in existing vaccines such as flu, hepatitis B, and cervical cancer vaccines. Unlike mRNA vaccines that are managed at a cryogenic temperature of -20 to -70°C, this vaccine can be stored refrigerated at 2 to 8°C, so it can be distributed using the existing vaccine distribution network. Recently, the clinical results of Novavax vaccine have been published. Novavax announced last month that Phase III clinical trial of NVX-CoV2373 conducted in the UK in 15,000 adults aged 18 to 84 showed an average of 89.3% preventive effect. The original COVID-19 that did not mutate was 95.6% more effective than the mRNA vaccine, which is considered to be the most effective. For the UK mutant virus and the South African mutant virus, the first vaccines currently under development were confirmed to be 85.6% and 60% respectively. Stanley C. Erck, CEO of NovaVax, said, "We are pleased to expand the partnership we have established for the global supply of NVX-CoV2373 with this agreement." He said, "We are sharing the urgent need to provide a safe and effective COVID-19 vaccine to humanity around the world, including Korea." Ahn Jae-yong, CEO of SK Bioscience, said, "It is of great significance that we have taken the initiative to overcome the pandemic at the national level by securing the technology itself, not simply by purchasing products." He said, "We will work with the government so that our people can get COVID-19 vaccine quickly."
- Company
- Does Propecia cause depression?
- by Eo, Yun-Ho Feb 17, 2021 05:40am
- It has already been reflected in the package insert such as Korea and Europe, and has not been directly proven to have a causal relationship. There was another controversy that the hair loss drug Propecia causes depression. Reuters reported on the 3rd (local time) of the lawsuit filed in the Brooklyn Federal Court of New York in connection with the side effects of Propecia. Since 2009, more than 200 cases of depression among people taking Propecia (Finasteride) have been received, and the developer MSD (Merck, USA) has covered up this. After the report, numerous Korean media spread the content, and in fact, there were even reports that Propecia could cause depression and suicide. This is an exaggeration. Prediction causes controversy, and controversy distorts facts. No one can define as 'true' in the current situation. The issue is whether MSD has concealed the reported adverse reaction cases and prevented the information from being reflected in US permits. Reports of abnormal cases cannot prove a causal relationship with the product. It cannot be concluded that the drug is the cause of the adverse event because an abnormal event has occurred after taking the drug. Brigham and Women's Hospital in US, for example, published an analysis that suggests that Propecia, a mechanism that inhibits the enzyme, may be associated with depression, based on the low levels of Allopregnanolone produced by the 5-alpha-reductase in male depressed patients. In a study published in the Dominican Republic of genetically followed patients with 5-alpha-reductase type 2 deficiency, there was also a study finding that there was no significant difference in depression or suicide frequency between the general population and the corresponding patient group. Kwang-sung Choi, chairman of Korean Hair Research Society (Professor of Dermatology at Inha University Hospital) said, "The reports of adverse reactions from Propecia mentioned in foreign news articles are the cumulative number of voluntary reports related to depression that occurred around the world for about 10 years since its launch in the US in 1998." He said, “Adverse reactions such as depression or suicide risk can be complexed by social, psychological, and economic factors in addition to medical factors. Depression-related cases that have occurred to date are simply those that occurred while taking drugs or were reported voluntarily.” So, did MSD really 'cover up' the facts? It is an obligation, not an option, for pharmaceutical companies to collect and report adverse events after obtaining marketing approval from health authorities and distributing them. The WHO's global adverse reaction database,'VigiBase', has already reported cases of Propecia's depression and mood swings. As mentioned by Reuters, cases of adverse reactions reported in Europe and Canada are already reflected in licenses and product manuals, and the MFDS also inserted the phrase 'depression and mood swings including suicide thoughts' in 2017. No country has stipulated that Propecia causes depression or mood swings. Taken together, it means that MSD has only concealed the phrase inserted in the permits already reflected in many countries in the US. It is also a drug that has been prescribed for over 20 years. Rather than taking the side of MSD, if it intentionally conceals facts, its morality should be blamed. In Korea, many people with hair loss are taking Propecia and are trembling with anxiety over this controversy. Chairman Kwang-Sung Choi said, "Propecia is a Rx drug. Hair loss diseases can be effectively and safely treated by treatment and prescription by specialists, and side effects are also managed through treatment. It is more damaging to stop hair loss treatment or receive the wrong treatment due to excessive fear of side effects or unproven claims.”
