Pfizer has announced that the Food and Drug Administration approved Paxlovid (nirmatrelvir tablets and ritonavir tablets) to treat mild-to-moderate COVID19 infected patients and those at risk of developing severe disease, including hospitalization and death.
Nirmatrelvir is a protease (Mpro) inhibitor that inhibits SARS-CoV-2 Mpro, an enzyme vital for replicating the COVID19 virus.
The approval is based on the Phase 2/3 EPIC-HR trial. The study enrolled adults at high risk of developing severe disease. There was a reduction of 89% in COVID19 related hospitalisation and no death compared to placebo within three days of symptoms onset. Further, it was reduced by 88% compared to placebo after five days of symptoms onset.
Pfizer has agreed to supply 10 million treatment courses in 2021 and 2022. The cost of each course is $530. Pfizer is planning to get complete authorization in 2022.
Pfizer also announced that it would supply 2.5 million doses of Paxlovid to the UK government, subject to the authorization.
Pfizer plans to supply 80 million courses in 2022, 30 million doses in the first half of 2022.