Nov 16, 2021 - Health

Pfizer asks FDA to authorize its COVID antiviral pill

Pfizer illustration
Photo: Soumyabrata Roy/NurPhoto via Getty Images

Pfizer said Tuesday it has asked the FDA for emergency authorization of Paxlovid, its experimental COVID-19 treatment.

Why it matters: Antiviral drugs can be a key pandemic-fighting tool, as not everyone will get vaccinated against the virus, Axios Caitlin Owens reports. If authorized, the drugs can also be administered at home.

Driving the news: The Pfizer pill regimen was shown in clinical trials to reduce the risk of hospitalization and death by 89% in people at high risk of severe illness, Pfizer said earlier this month.

  • The pill was developed specifically to treat COVID-19, by blocking the activity of the main enzyme the virus needs to multiply.

What they're saying: "The overwhelming efficacy achieved in our recent clinical study of Paxlovid, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19," Pfizer CEO and chair Albert Bourla said in a statement.

  • "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," Bourla added.

What to watch: The FDA said last month that it will hold an advisory meeting on Nov. 30 to review Merck's experimental oral antiviral COVID-19 treatment.

  • It has not yet said when it will discuss the Pfizer application.

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