Pfizer to seek FDA authorization of COVID-19 pill by Thanksgiving

Pfizer CEO Albert Bourla said last week he will ask the Food and Drug Administration to authorize by Thanksgiving a groundbreaking pill for treating COVID-19 after the drugmaker announced “game-changer” results from its clinical trial.

“We’ll do it very fast,” Mr. Bourla told CNBC on Friday.

The pill reduced the risk of hospitalization and death by 89% in a clinical trial involving more than 1,200 adults. Known as a protease inhibitor, the treatment attacks the part of the virus that it needs to replicate in human cells.

“This is a fantastic demonstration of the power of science. In fact, it’s coming a year almost to the day since we announced the results of the previous breakthrough, the vaccine, with 95% efficacy. It was Nov. 9 and now it’s Nov. 5,” Mr. Bourla said.

Last month, Merck said its pill treatment cut the risk of death or hospitalization by half. Though a lower efficacy than Pfizer’s, the company is further along in the regulatory process at the FDA and was recently authorized for use in the U.K.

Both products are considered ideal for persons who might be at higher risk of developing severe COVID-19. Unlike other therapeutics, pills are easy to administer and can be used at home, so their authorization would be a notable development.

Mr. Bourla said he doesn’t know how fast regulators will act on Pfizer’s product, but the company will have an initial supply of 500 million pills, which is 50 million treatments.

Mr. Bourla declined to say whether the drug would decrease the need for vaccine mandates, which are sparking political and legal fights across the country. He said that’s up to public health authorities, though he argued it should not decrease interest in the vaccine.

Pfizer’s two-dose vaccine is one of the leading options in the U.S. and many other countries.

“The fact we have a treatment is not at all a reason not to take the vaccine. In fact, we should take the vaccine,” Mr. Bourla said.

Some people will, unfortunately, get the disease so it is good news there is a treatment to reduce hospitalization, he said.

“Instead of 10 people going to hospitals, only one will go, this is basically what the results are telling us,” Mr. Bourla said. “The goal here is to prevent people from getting sick.”

Pfizer said during its study, 607 COVID-19 patients received the Pfizer treatment and low dose of an existing drug, ritonavir.

Six of them were hospitalized and none of them died.

In a placebo group of 612, there were 41 hospitalizations and 10 deaths.

Pfizer stopped enrolling people in the trial after a data-monitoring board consulted with the FDA and determined the results were so positive that the drugmaker should apply for emergency use authorization.

“I think this medicine will change the way things are happening right now,” Mr. Bourla said.