Merck COVID-19 oral drug: Emergency USE Authorization (EUA) Approved
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Merck’s COVID-19 oral drug Molnupiravir: Emergency USE Authorization Approved.
It was learned on the evening of November 30 that the FDA Drug Advisory Committee recommended the approval of Emergency USE Authorization for Merck’s Molnupiravir at 13:10 with a slight advantage.
Earlier (October 11), Merck announced that it had submitted Emergency USE Authorization (EUA) for the oral antiviral drug Molnupiravir (MK-4482) to the FDA.
Molnupiravir is a bioavailable form of oral ribonucleoside analog developed by Merck and its partner Ridgeback Biotherapeutics, which can inhibit the replication of SARS-CoV-2.
It is worth noting that the EUA is based on the positive interim analysis results of the Phase 3 clinical MOVe-OUT study. The trial evaluated Molnupiravir in non-hospitalized adult patients with mild to moderate COVID-19.
In the interim analysis, Molnupiravir reduced the risk of hospitalization or death by approximately 50% ; on the 29th day after randomization, 7.3% of patients treated with Molnupiravir were hospitalized or died (28/385), compared with placebo-treated patients. The ratio is 14.1% (53/377), p=0.0012. By day 29, there were no reports of deaths among patients receiving Molnupiravir, while 8 deaths were reported among patients receiving placebo. In terms of safety, the incidence of any adverse events in the Molnupiravir group and the placebo group was similar (35% and 40%, respectively), and the incidence of drug-related adverse events was also the same (12% and 11%, respectively).
However, on November 26, Merck and Ridgeback announced updated clinical data for the COVID-19 oral drug Molnupiravir for the treatment of mild to moderate COVID-19s.
According to the data of all admitted patients, reduce the hospitalization rate or mortality rate by 30% . There were 9 deaths in the placebo group and 1 death in the treatment group.
Merck COVID-19 oral drug: Emergency USE Authorization (EUA) Approved
(source:internet, reference only)
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