Pfizer seeks FDA approval of its Covid pill

by Jonathan Adams
Pfizer

Pfizer said it completed submission of its application for emergency use authorization of the drug with the U.S. FDA, including data from its clinical trial

Pfizer Inc said on Tuesday it is seeking U.S. authorization of its experimental antiviral COVID-19 pill that cut the chance of hospitalization or death for adults at risk of severe disease by 89% in a clinical trial.

Pfizer said it completed submission of its application for emergency use authorization (EUA) of the drug, Paxlovid, with the U.S. Food and Drug Administration (FDA), including data from its clinical trial.

The oral drug could be a promising new weapon in the fight against the pandemic, as it can be taken as an early at-home treatment to help prevent COVID-19 hospitalizations and deaths. It could also become an important tool in countries and areas with limited access to vaccines or low vaccination rates.

It is not immediately clear when U.S. regulators will rule on Pfizer’s application. Merck & Co and Ridgeback Biotherapeutics, which are developing a competing pill, molnupiravir, completed their EUA submission on Oct. 11.

A panel of outside advisers to the FDA will meet to consider that application on Nov. 30. It is expected to be available this year.

We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application, along with other regulatory agencies around the world, Pfizer Chief Executive Albert Bourla said in a news release.

A Pfizer spokesperson said that the data the company is submitting came from testing the medicine on unvaccinated, high-risk participants. The FDA will make the final decision on who the drug will be indicated for and how it can be used.



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