Pfizer is set to seek Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) for its antiviral COVID-19 treatment, according to BioSpace.
An interim analysis of Phase II/III data showed that the treatment is 89% effective at reducing the risk of hospitalization or death. The company said it is halting the study after the analysis was shown to be statistically and clinically meaningful.
Pfizer found that its antiviral drug Paxlovid showed positive results in patients within three days of treatment following the onset of COVID-19-related symptoms.
Paxlovid is a SARS-CoV-2 protease inhibitor antiviral therapy designed to block an enzyme that the coronavirus needs to replicate in the body. The drug is given along with a low-dose HIV drug ritonavir.
The company believes that Paxlovid could be advised as an at-home treatment to help reduce the severity of COVID illness, hospitalizations, and deaths.
Paxlovid will be the second oral antiviral drug submitted to the FDA in recent weeks. Merck is also planning to seek EUA for its COVID pill molnupiravir, which it co-developed with Ridgeback Biotherapeutics.
Last week, the UK authorized the use of molnupiravir within its healthcare system.
Pfizer CEO Albert Bourla called Paxlovid a “real game-changer in the global efforts to halt the devastation of this pandemic.” He said if the FDA approves Paxlovid, it will “potentially save the lives of infected individuals, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations.”
Bourla said in a statement, “Given the continued global impact of COVID-19, we have remained laser-focused on the science and fulfilling our responsibility to help healthcare systems and institutions around the world while ensuring equitable and broad access to people everywhere.”
Dr. Mikael Dolsten, Chief Scientific Officer and President of Worldwide Research, Development and Medical of Pfizer, said, “All of us at Pfizer are incredibly proud of our scientists, who designed and developed this molecule, working with the utmost urgency to help lessen the impact of this devastating disease on patients and their communities.”
