Merck/Ridgeback’s COVID-19 Drug Molnupiravir Met EUA Bar, But More Data Needed For Full Approval – US FDA
Reviewers believed it was worth making the oral antiviral available for second-line use under the relatively low bar for emergency authorization despite the drug’s significant potential risks, ‘modest benefit’ and ‘unexplained difference’ in efficacy results from the interim and full analysis populations in the pivotal trial.
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COVID pill’s EUA fact sheet includes the politically potent term ‘accessible,’ and the question of availability could be among the most important for the product – unless more clinical data turns it into a winner in its own right.
More generic deals but also US approval hurdles for Merck's oral antiviral, while Japan approves more options and Valneva's vaccine candidate shows promise against Omicron.
After lengthy review, Merck’s antiviral gets very restricted indication as part of its EUA, apparently reflecting concerns over safety and efficacy. But molnupiravir does appear to have some advantages over Pfizer’s Paxlovid – including that more of it will be available in the short term.