Pfizer asked the Food and Drug Administration on Tuesday to grant emergency authorization to its ‘game-changing’ antiviral COVID-19 pill, Paxlovid.
Earlier this month, the pharmaceutical giant announced that a five-day regiment of the drug reduced the risk of hospitalization and death by 89% in high-risk adults. Paxlovid was so successful, that Pfizer ended a clinical trial early so it could seek regulatory approval immediately.
“With more than 5 million deaths and countless lives impacted by this devastating disease globally, there is an urgent need for life-saving treatment options. The overwhelming efficacy achieved in our recent clinical study of PAXLOVID, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19,” Albert Bourla, chairman and CEO of Pfizer, said in a statement.
“We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application,” added Bourla. The Associated Press reports that the bill could be distributed “in the coming weeks.”
The Washington Post adds:
Pfizer is requesting authorization for people who are at increased risk of hospitalization due to age or underlying medical conditions, and the submission will add to a busy holiday season for regulators.
Scientists at the Food and Drug Administration are already poring over the data on molnupiravir, an antiviral pill developed by Merck and its partner Ridgeback Biotherapeutics that cut risk of hospitalization and death in half in a clinical trial that was also stopped early because the drug was clearly effective. An external advisory committee to the agency is scheduled to meet Nov. 30 to discuss the safety and effectiveness of molnupiravir.
“Paxlovid works by preventing the coronavirus from replicating inside cells. It combines two antivirals: an experimental compound called PF-07321332 and an existing drug called ritonavir, which is used in HIV treatments,” explains NBC News.
The Biden administration is expected to announce the purchase of 10 million courses of Paxlovid. The Post reports:
[Pfizer] has already started manufacturing the pill, and if the Food and Drug Administration clears it, the therapy could be available right away — though in very limited quantities. Pfizer has said it may have enough treatments to cover between 100,000 to 200,000 people by the end of the year and millions more in the first half of next year.
Earlier on Tuesday, Pfizer announced that it would share the formula for Paxlovid with a U.N.-backed group in an effort to make the drug available in poor countries.
The AP explains:
In a statement issued Tuesday, Pfizer said it would grant a license for the antiviral pill to the Geneva-based Medicines Patent Pool, which would let generic drug companies produce the pill for use in 95 countries, making up about 53% of the world’s population.
“It’s quite significant that we will be able to provide access to a drug that appears to be effective and has just been developed, to more than 4 billion people,” Esteban Burrone, head of policy at the Medicines Patent Pool, said.