Pfizer First: Oral Antiviral Paxlovid Wins EUA As Merck’s COVID Pill Languishes At US FDA
Authorized for mild-to-moderate COVID-19 in patients 12 and older at high risk for severe disease, Paxlovid (nirmatrelvir/ritonavir) jumped ahead of Merck & Co./Ridgeback’s molnupiravir in the EUA queue for oral antivirals, with the latter possibly hung up by efficacy and safety concerns.
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Oral antivirals make progress in Asia as Japan issues emergency approval to Merck's Lagevrio in a matter of weeks and South Korea clears Pfizer's contender Paxlovid. Vaccines also move forward in both countries with deals for boosters, new supply agreements and the advancement of home-grown candidates.
US regulators have granted emergency authorization to the antiviral molnupiravir but only for use when "alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate."
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.