Pfizer Seeks FDA Approval For COVID Treatment Pill, Will Let Others Use Formula
Image ID 210332358 © via Esther19775 | Dreamstime.com
Pfizer has announced that it’s seeking approval from the US Food and Drug Administration (FDA) for its new COVID-19 treatment pill, which could help medical providers tend to those at a higher risk of serious illness from the virus.
Additionally, the Medicines Patent Pool, an organization overseeing public medicine access, said that the drugmaker signed an agreement to share its license for the oral pill, allowing patients in lower-income countries to gain access to treatment.
The new medication, named Paxlovid, is a mix of the drug PF-07321332 and Ritonavir, which is currently used to treat HIV. Clinical trials conducted by Pfizer found that this combination could decrease the risk of hospitalization or death from COVID-19 by up to 89%.
According to CNET, at the moment, there isn’t a set date for the FDA to approve the treatment, though an independent committee will be meeting on November 30 to discuss an alternative treatment pill by Merck and Ridgeback Biotherapeutics, which has been green-lighted in the UK.
The voluntary license agreement, signed by Pfizer, will allow approved manufacturers around the world to access the medication’s formula, enabling them to produce and distribute the COVID treatment to over 95 countries, constituting 53% of the world’s population.
In a show of good will, the company will not be receiving any royalties from the sale of Paxlovid in low-income countries and will waive royalties for all countries included in the agreement for as long as the virus is classified as a “public health emergency of international concern” by the World Health Organization.
While the treatment doesn’t prevent an individual from contracting COVID, unlike a vaccine, it could help bring down the numbers of those severely affected by the virus, lessening the strain on hospitals and medical providers worldwide.
Numbers from Our World in Data show that only 4.6% of residents in low-income countries have had access to one dose of the vaccine, meaning that this new pill, once distributed, could lower the hospitalization and death rates in those regions markedly.
Ellen ’t Hoen, Director of Medicines Law & Policy, said Pfizer’s agreement to license the drug without royalties is “very good news.”
“This is setting the precedent that if you have a COVID-19 countermeasure, you license for wider use,” she told The Washington Post.
[via CNET, cover image via Esther19775 | Dreamstime.com]
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