Pfizer applied to FDA to approve its antiviral medication to treat Covid-19-positive patients, the company stated Tuesday.
If authorization is granted, the drug, which will be sold as Paxlovid in the United States, could be available within weeks. It can be purchased at pharmacies or taken at home.
Paxlovid, the second antiviral medication to prove its effectiveness against Covid is part of a new group of treatments for the disease. These treatments are expected to reach far more people than traditional infusion drugs.
Paxlovid was shown to dramatically reduce the risk of death or hospitalization in a pivotal clinical trial. It was administered to high-risk, unvaccinated volunteers shortly after they began to show symptoms. It appears to be more efficient than molnupiravir from Merck, which could be approved as soon a December.
Both pills are intended for people over 60, who have severe medical conditions or obesity that could make them more susceptible to becoming seriously ill with Covid.
Pfizer provided data proving the effectiveness of the treatment for high-risk unvaccinated individuals, but officials indicated that they could submit additional data as clinical trials progress. The F.D.A. The final decision on who can receive the pill is made by the F.D.A.
Merck, which applied last month for authorization for Molnupiravir, stated that it would be up the F.D.A. It will be up to the F.D.A to decide whether it is okay to use its pill in unvaccinated as well as vaccinated patients.
The F.D.A. has not yet said whether it would convene a meeting of expert advisers to recommend whether to authorize Pfizer’s treatment. A panel of experts that advises the agency on antimicrobial drugs is scheduled to meet at the end of this month to discuss Merck’s drug.
Supplies of Pfizer’s treatment, which is taken as a regimen of 30 pills over five days, will be very limited at first. Pfizer claimed it could make enough pills to treat 180,000 people by the end next year. Pfizer expects to increase manufacturing to produce at minimum 50 million treatment programs next year, with 21 million or more by June.
Australia and Britain have already secured some of these supplies. According to people familiar, the United States plans on buying approximately 10 million courses of treatment.
Pfizer stated Tuesday that it reached an agreement with other manufacturers to make and distribute the pill at a low price for use in 95 developing nations.
Pfizer’s drug is designed to stop the coronavirus from replicating by blocking the activity of a key enzyme that the coronavirus uses to replicate itself inside cells. Merck’s pill works differently, by inserting errors into the virus’s genetic code, a mechanism that has raised concerns among some scientists that Merck’s drug could trigger genetic mutations that cause reproductive harm. That difference could give Pfizer’s pill an advantage among doctors and patients, because it does not carry the same safety concerns as the Merck pill.
Source: NY Times