Pfizer seeking FDA approval for its experimental COVID antiviral pill

Pfizer Inc. is reportedly seeking authorization from the U.S. FDA for its experimental antiviral COVID-19 pill, Paxlovid. The drug has been shown to reduce the chance of hospitalization or death by 89% in adults with risk of severe disease, in a clinical trial.

Pfizer mentioned that it has completed its application to the U.S. Food and Drug Administration, for emergency use authorization (EUA) of the Paxlovid drug, along with data from the company’s clinical trial.

The oral drug can be taken as an early at-home treatment that can avoid hospitalization & death and could prove to be a promising weapon in the battle against the COVID-19 pandemic. It could also be highly useful in countries and areas with low vaccination rates or which have limited access to vaccines.

However, it is still unclear as to when U.S. regulators will decide on Pfizer’s application.

Notably, Merck & Co Inc. and Ridgeback Biotherapeutics, which are making molnupiravir, a competing pill, had submitted their EUA application on Oct. 11. A panel of outside advisers to the FDA are expected to meet to review their application on Nov. 30, and the drug is likely to be made available this year.

A Pfizer spokesperson mentioned that the data submitted by the company is based on a trial of the medicine on unvaccinated, high-risk participants. The FDA will ultimately decide on who the drug will be recommended for and the recommended dosage.

The company further stated that it has started the process of seeking authorization of the treatment in many countries including the United Kingdom, New Zealand, Australia, and South Korea, and intends on more international submissions.

Pfizer anticipates manufacturing around 180,000 treatment courses by the end of December, and no less than 50 million courses by 2022 end.

The company will allow generic manufacturers to deliver its pill to 95 low-and middle-income countries by entering into a licensing agreement with Medicines Patent Pool (MPP).

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https://newsinfo.inquirer.net/1516131/pfizer-files-for-us-authorization-of-promising-covid-19-antiviral-pill