Pfizer asks FDA for approval of ‘Paxlovid’ COVID-19 pill, inks deal allowing generics

Just hours after Pfizer announced it has made a deal with the Geneva-based Medicines Patent Pool (MPP) regarding the company’s COVID-19 pill, the company said Tuesday afternoon it is asking the Food and Drug Administration for emergency use authorization for the pill. The FDA will scrutinize company data on the safety and effectiveness of the drug, which would be sold under the name “Paxlovid”, and make a decision in the coming weeks.

“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,” Pfizer CEO Albert Bourla said in a news release. “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, along with other regulatory agencies around the world.”

Meanwhile, the deal with the U.N.-backed MPP, announced early Tuesday morning, will allow generic drug companies to produce the pill for use in 95 countries. Those countries cover about 53% of the world’s population. The video above shows officials talking about the deal.

“We believe oral antiviral treatments can play a vital role in reducing the severity of COVID-19 infections, decreasing the strain on our healthcare systems and saving lives,” Bourla said in a separate news release. “We must work to ensure that all people – regardless of where they live or their circumstances – have access to these breakthroughs, and we are pleased to be able to work with MPP to further our commitment to equity.”

According to the news release, Pfizer will not get any royalties “on sales in low-income countries”. Pfizer will also waive royalties for the countries included in the pill deal “while COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization”.

The deal is notable considering the fact that the Pfizer COVID-19 pill is not yet approved for use. Earlier this month, Pfizer announced it is planning to submit data for the pill to the Food and Drug Administration, after finding the pill “caused an 89% reduction in risk of COVID-19-related hospitalization or death”.

“This license is so important because, if authorized or approved, this oral drug is particularly well-suited for low- and middle-income countries and could play a critical role in saving lives, contributing to global efforts to fight the current pandemic,” MPP Executive Director Charles Gore said in Tuesday’s news release.

The MPP head of policy estimated that under the deal other drugmakers would be able to start producing the Pfizer COVID-19 pill within months. However, he also acknowledged the agreement wouldn’t please everyone.

“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 said.