Pfizer seeking FDA approval for its experimental COVID antiviral pill
Category: #healthcare  By Mateen Dalal  Date: 2021-11-18
  • share
  • Twitter
  • Facebook
  • LinkedIn

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).

Source Credits:

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

About Author

Mateen Dalal    

Mateen Dalal

Despite working as a professional testing engineer, Mateen Dalal always held a liking for content creation. Following his passion, he now pens down articles for itresearchbrief.com and a couple of similar portals. Mateen is a qualified electronics and telecommunicat...

Read More>>

More News By Mateen Dalal

Rockefeller Foundation donates $15Mn to fight AIDS, TB & Malaria
Rockefeller Foundation donates $15Mn to fight AIDS, TB & Malaria
By Mateen Dalal

The Rockefeller Foundation has reportedly announced that it intends to donate $15 million to the Glo...

Meta settles Facebook’s location tracking lawsuit at USD 37.5 million
Meta settles Facebook’s location tracking lawsuit at USD 37.5 million
By Mateen Dalal

According to recent court documents, Facebook parent Meta has settled worth USD 37.5 million for a l...

Toyota India reboots growth strategy, shifts focus to hybrid vehicles
Toyota India reboots growth strategy, shifts focus to hybrid vehicles
By Mateen Dalal

Leading Japanese automobile manufacturer, Toyota is reportedly rethinking its approach to the Indian...