Pfizer files for U.S. authorization of COVID-19 pill

An individual walks previous the Pfizer Headquarters constructing within the Manhattan borough of New York Metropolis, New York, U.S., December 7, 2020.

REUTERS/Carlo Allegri

Pfizer Inc stated on Tuesday it’s searching for U.S. authorization of its experimental antiviral COVID-19 pill that lower the possibility of hospitalization or demise for adults in danger of extreme illness by 89% in a medical trial.

Pfizer stated it accomplished submission of its software for emergency use authorization (EUA) of the drug, Paxlovid, with the U.S. Meals and Drug Administration, together with information from the drugmaker’s medical trial.

The oral drug may very well be promising new weapon within the struggle in opposition to the pandemic, as it may be taken as an early at-home remedy to assist forestall COVID-19 hopitalizations and deaths. It may additionally change into a necessary device in international locations and areas with restricted entry to vaccines or low vaccination charges.

It’s not instantly clear when U.S. regulators will rule on Pfizer’s software. Merck & Co Inc and Ridgeback Biotherapeutics, that are creating a competing pill, molnupiravir, accomplished their EUA submission on Oct. 11.

A panel of outdoors advisers to the FDA will meet to contemplate that software on Nov. 30, and it’s anticipated to be accessible this yr.

“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 Government Albert Bourla stated in a information launch.

The New York-based drugmaker stated it has begun the method of searching for authorization in a number of international locations together with the UK, Australia, New Zealand and South Korea, and plans additional worldwide submissions.

Pfizer stated earlier on Tuesday it’s going to permit generic producers to produce its COVID-19 pill to 95 low- and middle-income international locations via a licensing settlement with worldwide public well being group Medicines Patent Pool (MPP).

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