Pfizer requests US authorization for COVID-19 pill

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

Pfizer said it completed filing its application for an emergency use authorization (US) of the drug Paxlovid with the US Food and Drug Administration, including data from the drug manufacturer’s 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 treatment at home to help prevent hospitalizations and deaths from COVID-19. 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 US regulators will rule on Pfizer’s request. Merck & Co and Ridgeback Biotherapeutics, which are developing a competing pill, molnupiravir, completed their US filing on October 11.

A panel of external FDA advisers will meet to consider that request on November 30. It is expected to be available this year.

ALTHOUGH PRIME MINISTER Benjamin Netanyahu has touted his close relationship with Pfizer CEO Albert Bourla (on April 23), it was Levy who signed the first contract for eight million doses. (credit: JOHN THYS / POOL VIA REUTERS)

“We are moving as quickly as possible in our effort to bring this potential treatment into the hands of patients, and we look forward to working with the US FDA on reviewing our application, along with other regulatory agencies around the world. “said Pfizer. Chief Executive Albert Bourla said in a press release.

A Pfizer spokesperson said the data the company presents comes from testing the drug in unvaccinated high-risk participants. The FDA will make the final decision about who the drug will be directed to and how it can be used.

The New York-based drug maker said it has begun the process of seeking authorization for the treatment in several countries, including the UK, Australia, New Zealand and South Korea, and plans more international presentations.

Pfizer has said it expects to manufacture 180,000 treatment courses by the end of next month and at least 50 million courses by the end of 2022.

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

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