The Committee for Medicinal Products for Human Use (CHMP) has recommended that Pfizer’s (NYSE:PFE) COVID-19 pill be granted conditional marketing authorization.
Specifically, CHMP recommended that the antiviral, comprising PF-07321332 and ritonavir, be used in adults not requiring supplemental oxygen who face an elevated risk of severe COVID-19.
If the European Commission signs off on the drug, it could be the first oral antiviral available in the region.
The organization provided guidance on the potential use of the drug in December.
To reach its recent recommendation, CHMP scrutinized clinical data from a study demonstrating the drug significantly reduced the risk of hospitalization or death in patients at risk of developing severe COVID-19. That study found that 0.8% of Plaxovid recipients required more than 24 hours of hospitalization compared to 6.3% of those who got placebo. There were no deaths in the Plaxovid group, which comprised 1,039 p…