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 patients, but nine deaths were in the placebo group composed of 1,046 individuals.
The aforementioned analysis was conducted within five days after the onset of COVID-19 symptoms.
The majority of patients in the study were infected with the delta variant.
Pfizer anticipates that the antiviral will remain effective against the omicron variant based on laboratory studies.
Europe continues to contend with an unprecedented surge in COVID-19 cases. Reuters notes that approximately 47 out of every 100 infections reported worldwide are from Europe.
“We are proud to have a strong manufacturing footprint in Europe, which will help support the production of up to 120 million courses of PAXLOVID globally,” said Albert Bourla, Pfizer CEO, in a statement. “Pending conditional marketing authorization from the European Commission, we will continue working closely with EU Member State governments to ensure this important treatment can be made available to patients across Europe as quickly as possible.”
Filed Under: Infectious Disease