Pfizer asks FDA to approve promising COVID-19 pill

FILE – The Pfizer logo will be displayed at the company’s headquarters in New York on February 5, 2021. In a statement on Tuesday, November 16, 2021, drug manufacturer Pfizer Inc. stated that it has signed an agreement with a UN-backed group to allow other manufacturers to make its experimental coronavirus pill, in a move that could make its treatment available to more than half of the world’s population. (AP Photo / Mark Lennihan, File)

WASHINGTON (AP) – Pfizer said Tuesday that it is asking U.S. regulators to approve its experimental pill against COVID-19, setting the stage for a likely launch of the promising therapy in the coming weeks.

The company’s application comes as new infections rise again, primarily driven 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 reduce hospitalizations and deaths among people infected with COVID-19. If approved by the Food and Drug Administration, it can be a major step toward dealing with the pandemic and returning to normal, offering an easy and effective way for patients to treat themselves at home.

“We are moving as quickly as possible in our efforts to get this potential treatment in the hands of patients, and we look forward to working with the US FDA on its review of our application,” said Albert Bourla, Pfizer’s CEO, in a statement.

All FDA-authorized COVID-19 treatments require an IV or injection given by a healthcare professional in a hospital or clinic.

FDA regulators will examine the company’s data on the safety and efficacy of the drug, which will be sold as Paxlovid before making a decision.

The FDA is holding a public meeting later this month where external experts will review 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.

Some experts predict that over time, various COVID-19 therapies will be prescribed in combination to better protect against the worst effects of the virus.

Several smaller drug manufacturers are also expected to apply for permission for their own antiviral pills in the coming months.

Pfizer reported earlier this month that its pill reduced hospitalizations and deaths by 89% among high-risk adults who had early symptoms of COVID-19. The company examined its pill in people who were unvaccinated and faced the worst risks from the virus due to age or health problems, such as obesity. If approved, the FDA will have to weigh, making the pill available to vaccinated people dealing with breakthrough infections.

For best results, patients should start taking the pills within three days of symptoms, emphasizing the need for prompt testing and diagnosis. It could be a challenge if another COVID-19 increase leads to test delays and shortages, seen last winter.

Pfizer’s drug is part of a decades-old family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme that viruses need to multiply in the human body. It is different from the Merck pill, which causes small mutations in the coronavirus to the point that it cannot reproduce itself.

On Tuesday, Pfizer signed an agreement with a UN-backed group to allow generic drug manufacturers to produce low-cost versions of the drug for use in 95 countries, a move that could make treatment available to more than half the world’s population.

The United States has approved another antiviral drug against COVID-19, remdesivir, and approved three antibody therapies that help the immune system fight the virus. However, they usually have to be given via time-consuming infusions in hospitals or clinics, and limited supplies were burdened by the last wave of the delta variant.

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