Pfizer seeks EUA for Paxlovid, will allow generics of COVID-19 antiviral
Pfizer said Tuesday that it is seeking emergency use authorization from the FDA for its investigational COVID-19 pill and will allow generic drug makers to produce the novel antiviral for low- and middle-income countries.
The agreement to allow generics of the antiviral PF-07321332 — which is administered with low-dose ritonavir as Paxlovid — was signed with the Medicines Patent Pool (MPP) and will make the treatment widely available in 95 low- and middle-income countries, giving access to 53% of the world's population, according to Pfizer.
“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,” Charles Gore, executive director of MPP, said in a press release.
The agreement and the announcement that Pfizer would seek an EUA for Paxlovid in the United States came less than 2 weeks after the company announced early results from a trial that showed an 89% reduction in the risk of hospitalization or death from COVID-19 among people who received the treatment within the first 3 days of symptom onset.
Pfizer said that because of the “overwhelming efficacy” of the treatment, it would stop enrolling participants in the study and submit data to the FDA as part of an ongoing submission for an EUA.
“Pfizer remains committed to bringing forth scientific breakthroughs to help end this pandemic for all people,” Albert Bourla, DVM, PhD, chairman and chief executive officer of Pfizer, said in the 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.”
Pfizer said it has also begun opening rolling submissions for Paxlovid in other countries, including Australia, New Zealand, South Korea and the United Kingdom.
“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,” Bourla said in a release.
Pfizer and the MPP sign licensing agreement for COVID-19 oral antiviral treatment candidate to expand access in low- and middle-income countries. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-medicines-patent-pool-mpp-sign-licensing. Accessed Nov. 16, 2021.
Pfizer seeks emergency use authorization for novel COVID-19 oral antiviral candidate. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-seeks-emergency-use-authorization-novel-covid-19.Accessed Nov. 16, 2021.