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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US FDA’s decision to allow pharmacists to prescribe Pfizer’s COVID-19 antiviral raises hopes and fears that the idea that could be applied more broadly post-pandemic.
Data suggests fewer approvals and new product ideas, as the business case for new generic and brand treatments seems to be tougher to make now than at other times during the pandemic.
Lilly appeared to benefit from agency’s increased familiarity in treating COVID-19 with these types of biologics. Changing nature of the pandemic and the loss of utility of older antibodies due to the Omicron variant may have also played a role in the data required for latest EUA.