Thursday, October 6, 2022
Home Covid-19 Pfizer files for U.S. authorization of its pill to treat COVID-19

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

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, including data from the drugmaker’s clinical trial.

The oral drug could be 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 hopitalizations and deaths. It could also become a important tool in countries and areas with limited access to vaccines or low vaccination rates.

Read more:
New Pfizer COVID-19 pill reduces hospital, death risk by 90%, company says

Story continues below advertisement

It is not immediately clear when U.S. regulators will rule on Pfizer’s application. Merck & Co Inc 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, and 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.

The New York-based drugmaker said it has begun the process of seeking authorization in several countries including the United Kingdom, Australia, New Zealand and South Korea, and plans further international submissions.

Read more:
Pfizer to allow other companies to make its COVID-19 pill

Pfizer said earlier on Tuesday it will allow generic manufacturers to supply its COVID-19 pill to 95 low- and middle-income countries through a licensing agreement with international public health group Medicines Patent Pool (MPP).

© 2021 Reuters

Most Popular

Ian strengthens into major Category 3 hurricane as storm makes landfall in Cuba

Hurricane Ian strengthened into a major Category 3 storm early Tuesday morning as it made landfall in western Cuba, U.S. officials said.Landfall was just...

Hunting For An Exciting Back Yard Family Game, This Dad Invented His Own. Now It’s Taking Off.

Joe Bingham, a structural engineer from Ogden, Utah, was looking for a backyard game he could play with his seven kids, instead of driving...

Is the Market Overreacting with Shopify Stock?

Shares may have been overly punished by the markets Shopify continues to grow, but at a slower pace Shopify says 2022 is the ‘transition back to...

Comment on Following the Rules: Training Small Business Owners Better by Charles Iarocci

Your Business Professor was teaching our 5-year-old boy some basketball moves in our backyard court …Grab a jersey here. Push there. Lean. Scream.Charmaine looked out the...