Pfizer is seeking US authorization for its experimental COVID-19 treatment pill
WASHINGTON – Pfizer on Tuesday asked US regulators to authorize its experimental pill for COVID-19, setting the stage for a possible launch this winter of a promising treatment that can be taken at home.
The company’s filing comes as new infections are rising once again in the United States, primarily driven by hot spots in states where colder weather is driving more Americans indoors.
“We are moving forward as quickly as possible in our effort to get this potential treatment into the hands of patients,” Albert Boerla, Pfizer CEO, said in a statement, and we look forward to working with the US FDA on the review of our application. Looking forward.”
The FDA is holding a public meeting on the Merck Pill later this month to seek the opinion of outside experts before making a decision. The agency is not required to call such meetings and it is not yet known whether Pfizer’s drug will undergo a similar public review.
Some experts predict that COVID-19 treatments will eventually be combined to better protect against the virus’s worst effects.
Pfizer reported earlier this month that its pill cut hospitalizations and deaths by 89% in high-risk adults who had early symptoms of COVID-19. The company studied its pill on people who had not been vaccinated and faced the worst exposure to the virus because of age or health problems, such as obesity. If authorized, the FDA would have to weigh in on making the pill available to vaccinated people who have contracted the breakthrough infection, as they were not part of the initial trials.
For best results, patients should begin taking the tablets within three days of symptoms, underscoring the need for early testing and diagnosis. It could be a challenge if another COVID-19 surge leads to testing 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 the virus needs to multiply in the human body. This is different from the Merck pill, which causes small mutations in the coronavirus until it can reproduce itself.
Pfizer on Tuesday signed a deal with the United Nations-backed group to allow generic drug makers to produce low-cost versions of the pill for some countries. Merck has a similar deal for its pill, which was approved in the UK earlier this month.
The US has approved another antiviral drug, remdesivir, for COVID-19, and authorized three antibody therapies that help the immune system fight the virus. But they are usually given by healthcare professionals via a time-consuming infusion, and limited supplies are affected by the eventual surge of the delta version.
The US government is already committed to buying Merck’s pill. Federal officials were in talks with Pfizer to buy millions of doses of the pill, according to an official familiar with the matter.
Report Zeke Miller in Washington contributed.
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