Pfizer asks US officials to approve promising COVID-19 pills

Pfizer asks US officials to approve promising COVID-19 pills

Washington — Pfizer Inc said Tuesday it is asking US regulators to approve its experimental COVID-19 pills, paving the way for a possible launch of the promising treatment in the coming weeks.

The company’s filing comes as new infections are on the rise again, driven primarily by hot spots in the states where cold 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 with COVID-19. If authorized by the Food and Drug Administration, it could be a major step toward managing the epidemic and returning to normal, providing 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 into patients’ hands, and we look forward to working with the FDA on its review of our application,” Pfizer CEO Albert Burla said in a statement. .

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All FDA-approved treatments for COVID-19 require an intravenous injection or injection given by a health professional in a hospital or clinic.

Regulators at the US Food and Drug Administration (FDA) will check the company’s data on the safety and efficacy of the drug, which will be sold as Paxlovid, before making any decision.

The US Food and Drug Administration is holding a public meeting later this month where outside experts will examine a competing drug from Merck, before voting to recommend approval. The FDA is not required to hold such meetings and it is not yet known whether Pfizer will undergo a similar public review.

Some experts predict that many COVID-19 treatments will eventually be prescribed together to better protect against the worst effects of the virus.

It is also expected that several smaller drug makers will seek a license for their antiviral tablets in the coming months.

Pfizer reported earlier this month that its pills reduced hospitalizations and deaths by 89% among high-risk adults who developed early symptoms of COVID-19. The company studied its pills on unvaccinated people who faced the worst risks of the virus due to age or health problems such as obesity. If authorized, the Food and Drug Administration (FDA) would have to weigh the availability of the pill for vaccinated people who are dealing with a breakthrough infection.

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For best results, patients need to start taking the pills within three days of symptoms appearing, which underscores the need for rapid testing and diagnosis. This could prove challenging if another surge in COVID-19 tests the delays and shortages we saw last winter.

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

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

The United States has approved another antiviral drug for COVID-19, remdesivir, and has authorized three antibody therapies that help the immune system fight the virus. But they usually have to be given by injections that take a long time in hospitals or clinics, and limited supplies have been strained by the recent rise in the delta variable.

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