Pfizer’s COVID pill wins FDA emergency-use authorization

U.S. regulators gave emergency authorization to Pfizer Inc.’s COVID-19 pill for people at high risk of severe complications, bringing a more convenient treatment option to patients at a critical point in the pandemic.

The drug Paxlovid becomes the first at-home medication authorized for COVID-19. It is expected to become a potent weapon in battling the virus once production gears up, giving high-risk patients an easyto-use treatment they can take from home.

“This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge,” said Patrizia Cavazzoni, director of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, in a statement on Wednesday.

Shares of Pfizer gained as much as 2.8% as of 12:26 p.m. in New York, and have surged 64% this year.

U.S. regulators are expected to authorize a second pill for COVID-19, Merck & Co.’s molnupiravir, as soon as Wednesday, according to officials familiar with the plans.

In a large clinical trial, Paxlovid was shown to reduce hospitalizations by 89% when it was given to high-risk unvaccinated patients within three days of symptoms starting. Adverse events associated with the drug have been similar to a placebo in clinical trials, Pfizer has said.

But the supply will be sharply limited at first, before ramping up next year. While the U.S. government has ordered 10 million courses of the Pfizer pill, it expects to have only 65,000 courses available right away, and 250,000 courses by the end of January, U.S. officials have said.

“Pfizer stands ready to begin delivery in the U.S. immediately,” Pfizer Chief Executive Officer Albert Bourla said in a statement.

Supply of the pill is expected to ramp up dramatically next year, when Pfizer expects to produce 120 million courses.

Until now, infused monoclonal antibodies have been the mainstay treatment for high-risk COVID-19 patients outside of the hospital. But those are complicated to administer and target the fast-mutating spike protein.

By contrast, Pfizer’s pill targets a protein inside the virus that is thought to mutate infrequently. Pfizer’s lab tests indicate that Paxlovid will still work against omicron.

Currently the mainstay treatments in the U.S. are monoclonal antibody therapies from Eli Lilly & Co. and Regeneron Pharmaceuticals Inc. that target the fast-mutating spike protein. Early lab tests indicate that antibodies may be far less effective against omicron.

Side effects of Paxlovid could include impaired sense of taste, diarrhea, high blood pressure and muscle aches, the FDA said in its statement.

The pill was authorized for treating symptomatic COVID-19 in patients 12 years and older at high risk of developing severe disease. It is taken twice a day for five days and is used in conjunction with a second drug called ritonavir.