Pfizer Asks FDA for Emergency Approval of Its COVID Antiviral Pill
TUESDAY, Nov. 16, 2021 (HealthDay News) -- Pfizer announced Tuesday that it has asked the U.S. Food and Drug Administration to approve the emergency use of its new antiviral pill in people at high risk for severe COVID-19.
"With more than 5 million deaths and countless lives impacted by this devastating disease globally, there is an urgent need for life-saving treatment options. 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 chairman and CEO Albert Bourla, said in a company 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."
The request comes shortly after the company said that clinical trial testing of a five-day treatment regimen with the drug, Paxlovid, was halted early due to overwhelming evidence of its effectiveness.
In the trial, people at high risk for severe illness had an 89% lower risk of hospitalization and death if they started taking Paxlovid within three days of symptom onset, compared to those who received a placebo.
Accordingly, Pfizer is seeking authorization for the drug's use in people at increased risk of hospitalization due to age or underlying medical conditions. However, it is also testing the drug in people who are at low risk of severe outcomes and in those who have been exposed to the coronavirus.
Paxlovid is a combination of a new molecule developed specifically to disable SARS-CoV-2 and ritonavir, an HIV medication that helps slow the breakdown of the coronavirus-specific molecule.
The company has begun manufacturing and packaging the drug in factories in Ireland, Germany and Italy, and it has projected having 180,000 pill packs available by the end of the year and 50 million in 2022, the Washington Post reported. Meanwhile, the Biden administration is expected to announce this week that it has purchased 10 million courses of Paxlovid.
The FDA is already reviewing data on Merck's antiviral COVID-19 pill, molnupiravir, and an external advisory committee is set to meet on Nov. 30 to assess its safety and effectiveness.
Merck also halted its clinical trial of molnupiravir after concluding that it cut the risk of hospitalization and death in half. The Biden administration has already purchased 3.1 million treatment courses of Merck's drug, for $2.2 billion.
An FDA spokeswoman did not respond to questions about when an advisory panel might meet to discuss the Pfizer drug, the Post reported.
Visit the U.S. Centers for Disease Control and Prevention for more on COVID treatments.
SOURCES: Pfizer, Inc., news release, Nov. 16, 2021; Washington Post