Pfizer has filed its application with the FDA for Emergency Use Authorization (EUA) of its investigational oral antiviral candidate, Paxlovid, for the treatment of mild-to-moderate COVID-19 in patients at increased risk of hospitalization or death.

Earlier this month, an interim analysis of a phase 2/3 study showed that the drug cut the risk of COVID-19-associated hospitalizations and death by 89 percent compared to placebo. The study was stopped due to “overwhelming efficacy,” the company said (DID, Nov. 9).

If approved, Paxlovid would be the first oral antiviral of its kind — a 3CL protease inhibitor — that could be prescribed as an at-home treatment to high-risk patients at the first sign of infection, potentially helping patients avoid severe illness.

“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,” said Albert Bourla, chairman and CEO of Pfizer, in a statement.

Paxlovid is hot on the heels of Merck’s and Ridgeback Biotherapeutics’ oral antiviral COVID-19 medication molnupiravir, which got its first green light from a regulatory body in early November when the UK approved it, making it the first oral antiviral medicine authorized for the treatment of COVID-19 (DID, Nov. 5).

Pfizer this week signed an agreement with the Medicines Patent Pool, allowing the pool to make deals with other drugmakers in order to create generic versions of Paxlovid for 95 low- and middle-income countries.

Paxlovid doesn't yet have approval from any regulatory bodies.

Also in the race to get an oral COVID-19 treatment to market is Gilead Sciences, which is developing oral treatments for nonhospitalized patients and hopes to file investigational new drug applications with the FDA by early next year (DID, Sept. 24).  — Suz Redfearn