Pfizer seeks approval for COVID-19 treatment pill, eye rollout in coming weeks
Pfizer has said it is asking U.S. regulators to clear its experimental treatment pill for COVID-19, paving the way for a likely launch of the promising therapy in the coming weeks.
The company’s filing comes as new infections rise again, mostly due to hot spots in states where colder weather is pushing more Americans indoors.
It is one of the few pills that have recently been shown to dramatically reduce hospitalizations and deaths in people infected with COVID-19. If cleared by the Food and Drug Administration, it could be a major step toward managing the pandemic and getting back to normalcy, providing patients with a simple and effective way to self-care at home.
“We are moving forward as quickly as possible in our efforts to get this potential treatment into the hands of patients, and we look forward to working with the US FDA on reviewing our application,” said Albert Bourla, CEO of Pfizer, in a statement. .
All FDA-approved treatments for COVID-19 require an intravenous or injection administered by a healthcare professional in a hospital or clinic.
FDA regulators will carefully review the company’s data on the safety and effectiveness of the drug, which will be sold as Paxlovid, before making a decision.
The FDA will hold 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 under no obligation to call such meetings, and it is not yet clear whether Pfizer’s drug will undergo a similar public review.
Some experts predict that various COVID-19 therapies will eventually be prescribed in combination to better protect against the worst effects of the virus.
Several smaller drugmakers are also expected to seek approval for their own antiviral pills in the coming months.
Pfizer reported earlier this month that its pill reduced hospitalizations and deaths by 89% in high-risk adults who showed early symptoms of COVID-19. The company has studied its pill in people who have not been vaccinated and who face the worst risks of the virus due to age or health concerns, such as obesity. If approved, the FDA will need to assess the availability of the pill to vaccinated people with breakthrough infections.
For best results, patients should start taking the pills within three days of symptoms, which highlights the need for rapid testing and diagnosis. It could be a challenge if another wave of COVID-19 results in 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 have revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme including viruses need to multiply in the human body. It’s different from the Merck pill, which causes tiny mutations in the coronavirus to the point where it can’t reproduce.
On Tuesday, Pfizer signed an agreement with a UN-backed group to allow generic drug makers to produce low-cost versions of the drug for use in 95 countries, a move that could make the treatment available for more than half. of the world’s population.
The United States has approved another antiviral drug for COVID-19, remdesivir, and authorized three antibody therapies that help the immune system fight the virus. But they usually have to be given via time-consuming infusions in hospitals or clinics, and limited supplies have been strained by the latest wave of the delta variant.