Pfizer Asks FDA for Emergency Approval of Its COVID-19 Antiviral Pill
Request comes shortly after clinical trial testing the drug was halted early due to overwhelming evidence of its effectiveness
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," Pfizer Chairman and CEO Albert Bourla, said in a company statement. "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."
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 percent lower risk for hospitalization and death if they started taking Paxlovid within three days of symptom onset compared with those who received a placebo.
Accordingly, Pfizer is seeking authorization for the drug's use in people at increased risk for hospitalization due to age or underlying medical conditions. However, it is also testing the drug in people who are at low risk for severe outcomes and in those who have been exposed to COVID-19.
Paxlovid is a combination of a new molecule developed specifically to disable severe acute respiratory syndrome coronavirus 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.