Pfizer asks U.S. authorities to accept promising COVID-19 pills

Washington-Pfizer requested US regulatory authorities to approve the COVID-19 drug on Tuesday, preparing for this winter’s launch of a promising treatment that can be taken at home.

The company’s application comes primarily from the renewed increase in new infections in the United States, mainly caused by state hotspots where the cold climate drives more Americans indoors.

Pfizer pills have been shown to significantly reduce patient hospitalization and mortality rates coronavirus Infection. The Food and Drug Administration is already considering competing tablets from Merck, and some small pharmaceutical companies are expected to seek approval for their own antivirals in the coming months.

In a statement, Pfizer CEO Albert Bourla said, “We are acting as quickly as possible to bring this potential treatment to the hands of our patients, and we are working with the US FDA to apply. I am looking forward to conducting a review of. “

Specifically, Pfizer wants a drug that is available to adults who have mild to moderate COVID-19 infections and are at risk of becoming seriously ill. This is similar to the way other drugs are currently used to treat this disease. However, all FDA-approved COVID-19 treatments require IV or injection. health Hospital and clinic specialists.

The FDA is holding a public meeting on Merckpill later this month to get the opinion of outside experts before making a decision. The agency does not need to convene such a meeting and it is not yet known if Pfizer’s drug will receive a similar public review.

Some experts predict that COVID-19 treatment will eventually be combined to better protect against the worst effects of the virus.

Earlier this month, Pfizer reported a 89% reduction in hospitalization and mortality in high-risk adults with early signs of COVID-19. The company studied pills for people who have not been vaccinated and are facing the worst risk of the virus due to health problems such as age and obesity. If approved, the FDA should consider making the pill available to vaccinated people to combat breakthrough infections. Because they weren’t part of the first test.

For best results, patients should start taking tablets within 3 days of symptoms, emphasizing the need for prompt testing and diagnosis. If another COVID-19 surge leads to the test delays and shortages seen last winter, it can be a challenge.

Pfizer’s drugs are part of a decade-old family of antiviral drugs known as protease inhibitors that have revolutionized the treatment of HIV and hepatitis C. These drugs block important enzymes that the virus needs to multiply in the human body. This is different from the Merckpill, which causes a small mutation in the coronavirus until the coronavirus is unable to replicate itself.

On Tuesday, Pfizer signed a contract with a UN-backed group to enable generic drug manufacturers to produce low-cost tablets for specific countries. Merck has made similar deals on pills approved in the UK earlier this month.

The United States has approved another antiviral drug for COVID-19, remdesivir, and three antibody therapies that help the immune system fight the virus. However, they usually need to be given via time-consuming injections by medical professionals, and the limited supply was strained by the final surge of delta variants.

The US government has already promised to buy Merck pills. Federal officials were in talks with Pfizer to buy millions of tablets, officials familiar with the matter said.

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Contributed by Zeke Miller of Washington, Associated Press.

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Follow Matthew Perrone twitter: @AP — FDAwriter

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The Associated Press’s Department of Health Sciences is supported by the Science Education Department of the Howard Hughes Medical Institute. AP is solely responsible for all content.