Pfizer is seeking permission from the U.S. COVID-19 pill by Reuters

By Michael Erman

(Reuters) – Pfizer Inc (NYSE 🙂 said on Tuesday that it is seeking US permission in a clinical trial for an experimental antiviral pill for COVID-19 that reduces the chances of hospitalization or death of adults at risk of serious illness by 89%.

Pfizer said it had filed an application for emergency use of the drug Paxlovid (USA) with the U.S. Food and Drug Administration, including clinical trial data for the drug https://www.reuters.com/business/healthcare-pharmacy/pfizer-says-pill-antiviral-risk -cut-severe-covid-19-from-89-2021-11-05.

Oral medicine could be a promising new weapon in the fight against the pandemic, as it can be considered as an early home treatment to help prevent COVID-19 hospitalizations and deaths. It can 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 resolve Pfizer’s application. Merck & Co Inc. and Ridgeback Biotherapeutics, which are developing a competing pill, molnupiravir, ended their U.S. shipment on Oct. 11.

A panel of FDA external consultants will meet on Nov. 30 to review the app, which is expected to be available this year.

“We are working to make this potential treatment available to patients as soon as possible, and we look forward to working with the U.S. FDA to review our application, along with other regulatory agencies around the world,” Pfizer said. CEO Albert Bourla said in a news release.

The New York-based drug maker said it has begun the process of applying for a permit in several countries, including the UK, Australia, New Zealand and South Korea, and is planning more international shipments.

Pfizer said earlier Tuesday that it would allow generic manufacturers to supply the COVID-19 pill to 95 low- and middle-income countries through a licensing agreement with the Medicines Patent Pool (NASDAQ 🙂 (MPP) international public health team.