WASHINGTON — Pfizer says today it is asking US regulators to authorize its experimental pill for COVID-19, setting the stage for a likely launch of the promising therapy in the coming weeks.
The company’s filing comes as new infections are rising once again, driven mainly by hot spots in states where colder weather is driving more Americans indoors.
It is one of a handful of pills that have recently been shown to significantly cut hospitalizations and deaths among people infected with COVID-19. If authorized by the US Food and Drug Administration, it could be a major step toward managing the pandemic and returning to normal, offering an easy, effective way for patients people to treat themselves at home.
“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 US FDA on its review of our application,” says Albert Bourla, Pfizer’s CEO, in a statement.
All FDA authorized treatments against COVID-19 require an IV or injection given by a health professional at a hospital or clinic.
FDA regulators will scrutinize company data on the safety and effectiveness of the drug, which will be sold as Paxlovid, before making a decision.
The FDA is holding a public meeting later this month where outside experts will scrutinize a competing drug from Merck, before voting on whether to recommend approval. The FDA is not required to convene such meetings and it is not yet known whether Pfizer’s drug will undergo a similar public review.