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Introduction of oral tx for COVID-19
by Whang, byung-woo Dec 31, 2021 05:50am
As the U.S. Food and Drug Administration (FDA) has approved the emergency use of Pfizer's Paxlovid, the entry of oral coronavirus treatments into the market is just around the corner. On the 22nd (local time), the FDA approved the use of Paxlovid at home for high-risk adults, children over the age of 12, and patients with underlying diseases who are likely to be hospitalized in the event of COVID-19. According to the results of interim analysis of EPIC-HR, a phase 2/3 clinical trial of Paxlovid, the risk of hospitalization or death decreased by 89% in the patient group who administered the treatment within three days of symptom onset. This is higher than 50% of MSD's Molnupiravir, which previously announced interim results. In addition, Paxlovid had 0.8% (3/389) of patients hospitalized until the 28th day after random assignment, while the placebo group reached 7% (27/325). In addition, similar results were found in patients treated within 5 days of onset of symptoms. The proportion of inpatients in the Paxlovid treatment group was significantly higher at 1.0% (6/607), 6.7% (41/612) in the placebo group, and the effect of reducing hospitalization or death was 85%. In the case of Molnupiravir, 800 mg was taken twice a day and 10 times a day for 5 days, and 7.3% of patients worsened to severe and there were no deaths. 14.1% of patients taking placebo worsened to severe and 8 died, the survey showed. Kang Jin-han, head of the Vaccine Bio Research Institute at the Catholic University of Korea, said, "The reason for getting the vaccine is to prevent it from becoming severe, and even if it is a breakthrough infection, it is important to prevent medical confusion by administering oral treatments early." However, as in the early days of the introduction of the COVID-19 vaccine, supply problems remain. Paxlovid is expected to be supplied 265,000 times to the United States as early as January 2022. Paxlovid classifies 30 tablets into one batch, and the U.S. government has signed a contract for 10 million times for 530 dollars (about 630,000 won) per Paxlovid. According to Pfizer, Paxlovid, which has already been produced, is about 180,000 times, making it difficult to even digest contracts with the U.S. In response, Pfizer plans to raise its production capacity from 80 million times to 120 million times next year. In Korea, the Ministry of Food and Drug Safety also signed a contract to bring in about 70,000 installments with the emergency approval of Paxlovid, but considering that supply contracts continue around the world, it is difficult to estimate the exact timing of supply. However, there was also a view that even if the supply was insufficient, the timing would be more important than the supply as it was not conducted for the entire population like vaccines. Professor Choi Young-joon (pediatric infection) of Korea University Anam Hospital said, "In the case of vaccines, the population group was targeted, so vaccines were needed in millions to 10 million units," adding, "But in the case of treatments, setting an appropriate patient group will be more important." Mollupiravir influence? However, if Molnupiravir is approved for emergency use by the FDA following Paxlovid, the burden of supply may be shared. The problem is that there are still concerns about whether to use Mollupiravir, which is less effective than Paxlovid. Molnupiravir was evaluated as a game changer when it was released, but after discussing whether to use it during the FDA Advisory Committee review process, he managed to pass the approval recommendation with 13 votes in favor and 10 votes against. In particular, the actual effect was lowered to 30% in this process. In the case of Molnupiravir, a total of 40 tablets are taken at a time during the one-time treatment process, and the price per minute is known to be around 830,000 won, making it less competitive than Paxlovid.