Pfizer asks FDA to authorize its COVID pill treatment
The drugmaker also announces an agreement to share its license for the treatment, increasing access for low-income countries.
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Pfizer said Tuesday that it's asked the US Food and Drug Administration to authorize its medicine for people at increased risk of hospitalization or death from COVID-19. Earlier on Tuesday, Pfizer and the Medicines Patent Pool, a public health organization that advocates for medicine access, said the drugmaker signed an agreement to share its license for its oral antiviral COVID-19 treatment.
The treatment, called Paxlovid, is a combination of the drug PF-07321332 and ritonavir, a drug used to treat HIV. The treatment was found to decrease risk of hospitalization or death from COVID-19 by 89% in a clinical trial, Pfizer said.
There isn't a timeline for when the FDA will consider Paxlovid yet, but an independent committee to the FDA is meeting on Nov. 30 to discuss authorization of Merck's COVID-19 pill treatment.
Earlier in the day, Pfizer announced a voluntary license agreement on Paxlovid that will give qualified manufacturers around the world the formula of the medicine, allowing them to produce and distribute the antiviral to 95 countries and about 53% of the world's population, according to a news release.
Pfizer said it won't receive royalties on sales in low-income countries, and will waive royalties in all countries covered by the agreement while COVID-19 is classified as a "public health emergency of international concern" by the World Health Organization.
While the medicine does not prevent COVID-19, having a pill available to people in countries without access to coronavirus vaccines would be a huge step in minimizing deaths from the pandemic. Only 4.6% of people in low-income countries have received at least one dose of a COVID-19 vaccine, according to Our World in Data.
Pfizer hasn't agreed to a similar sharing of its COVID-19 vaccine formula. Pfizer's vaccine is the only COVID-19 vaccine with full approval by the FDA, rather than emergency use authorization.
The drugmaker did sign an agreement in September with the US that it would sell 500 million vaccine doses to the government at a not-for-profit price for the country to donate to other nations.
Merck, the maker of another promising COVID-19 antiviral, said in October that it agreed to share its license with lower-income countries, also pending local regulatory processes.
"This is setting the precedent that if you have a COVID-19 countermeasure, you license for wider use," Ellen 't Hoen, a member of a Medicines Patent Pool expert advisory group, told the Washington Post.