12/23/2021
Best news in a long time ! The U.S. FDA has approved the emergency authorization use of Pfizer’s inhibitor of the SARS-CoV-2 novel main protease (Mpro). The therapy is authorized for use in high-risk individuals of 12 years and older. Paxlovid contains two oral drugs, one (nirmatrelvir) blocking the viral protease, and a second one (ritonavir) enhancing the half-life of the SARS-CoV-2 inhibitor. Paxlovid is positioned to play a key role in the pandemic, at a time when the Omicron variant is escaping neutralization by vaccine and convalescent antibodies, and the only treatments available have limited therapeutic effects, or their availability is limited. Only one of the three therapeutic antibodies in use in the U.S. (sotrovimab, by Glaxo -Vir Bio) is active against omicron, and its availability may be limited in the near future. Pfizer’s small-molecule inhibitor can be mass-produced, and will be a key therapy for immunocompromised individuals and others at high-risk of severe infection. FDA EUA letter available at https://lnkd.in/gzW2uewm
