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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Paxlovid Is First COVID-19 Rx Product To Get AdComm On Move From EUA To Full Approval
Approval seems assured, but US FDA advisory committee is forum for sharing evidence for use of Paxlovid in those infected with the Omicron variant and in immunocompromised individuals, as well as discussing the Pfizer product’s possible association with COVID-19 rebound.
As COVID Public Health Emergency Winds Down, US FDA Employs Flexibility For Rx EUA Transitions
Biden administration sets May 11 as end date for public health emergency. CDER has said it will work with sponsors to help them gain approval of COVID therapeutics cleared under emergency use authorizations, but agency will likely not issue a formal transition framework.
Pfizer R&D Chief Mikael Dolsten Reflects On The COVID-19 Pandemic Experience
"I still remember how I screamed 'oh my god, it's just unbelievable,'" worldwide president R&D Mikael Dolsten told Scrip, reflecting on the moment he heard the first COVID-19 vaccine results.