Pfizer asks US officials to approve promising COVID-19 pills
Washington Pfizer asked US regulators on Tuesday to approve its experimental COVID-19 pill, paving the way for a possible launch this winter of a promising home-based treatment.
The company’s filing comes as new infections are on the rise again in the United States, driven primarily by hot spots in the states where cold weather is driving more Americans indoors.
It has been proven that Pfizer pills significantly reduced the rate of hospitalizations and deaths among those infected with the Corona virus. The Food and Drug Administration is already reviewing a competing pill from Merck and several smaller drug makers are also expected to seek a license for their antiviral pills in the coming months.
“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.
Specifically, Pfizer wants the drug available to adults with mild to moderate COVID-19 infection who are at risk of developing serious illness. This is similar to how other medicines are currently used to treat disease. But all FDA-authorized COVID-19 treatments require an intravenous injection or injection given by a health professional in a hospital or clinic.
The FDA is holding a public meeting on Merck’s pills later this month to get the opinion of outside experts before making its decision. The agency 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 treatments for COVID-19 will eventually be combined to provide better protection from the worst effects of the virus.
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 FDA would have to weigh the issue of making the pill available to vaccinated people dealing with sudden infections, since they weren’t part of the initial testing.
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 manufacturers to produce low-cost versions of the birth control pill for some countries. Merck struck a similar deal for its pills, which were licensed in Britain earlier this month.
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 time-consuming injections by health professionals, and limited supplies have been strained by the recent rise in the delta variant.
The US government has already committed to buying Merck’s pills. Federal authorities are in negotiations with Pfizer to purchase millions of doses of its pills, according to an official familiar with the matter.
Associated Press reporting contributed by Zeke Miller in Washington.
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