The company’s proposed COVID-19 treatment proved to be 89 percent effective in preventing hospitalization.
Pfizer says their new COVID-19 antiviral pill can significantly reduce hospitalization and death due to the disease and they plan to seek emergency use authorization for the drug from the Food and Drug Administration (FDA).
According to a news release, PAXLOVID was shown to be 89 percent effective in an interim analysis of Phase 2/3 EPIC-HR study of non-hospitalized adult patients with COVID-19 who are at-risk of progressing to severe illness. Only three patients who received the antiviral pill were hospitalized due to COVID-19 and none died of the disease, compared to 27 patients on the placebo who were hospitalized and seven who died.
The company has ceased further enrollment into the study due to the overwhelming efficacy, citing the recommendation of an independent data monitoring committee and the FDA, the release says.
“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic,” Albert Bourla, chairman and CEO of Pfizer, says in the release. “These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations. 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.”
The company sees PAXLOVID as being prescribed broadly as an at-home treatment to reduce severity, hospitalizations, and deaths due to COVID-19. It could also be used to reduce the probability of infection after exposure among adult, according to the release.
“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,” Mikael Dolsten, MD, PhD, chief scientific officer and president of worldwide research, development and medical at Pfizer, says in the release. “We’re thankful to all of the patients, investigators, and sites around the world who participated in this clinical trial, all with the common goal of bringing forth a breakthrough oral therapy to help combat COVID-19.”
Pfizer isn’t the first drug maker to tout a COVID-19 antiviral pill. Merck and Ridgeback Biotherapeutics have submitted an application for emergency use authorization to the Food and Drug Administration and other global regulatory bodies for the investigational antiviral pill, molnupiravir, for the treatment of mild-to-moderate COVID-19 in adults.
As previously reported, a planned interim analysis of a Phase 3 MOVe-OUT trial in 775 at risk, non-hospitalized adult patients with mild to moderate COVID-19 found that the antiviral reduced the risk of hospitalization or death by 50 percent. No patients who received the pill died after 29 days compared to eight who died after receiving a placebo.
The company plans to produce 10 million courses of treatment by the end of the year and previously entered into an agreement with the federal government to supply about 1.7 million courses of molnupiravir upon receiving an EUA or approval from the FDA. Merck has struck similar deals with other countries.
Last week, the company signed a voluntary licensing agreement with the Medical Patent Pool (MPP) in an effort to facilitate affordable access for the proposed antiviral pill, molnupiravir, in 105 low- and middle-income countries following regulatory approvals. This is the first MPP agreement for a COVID-19 medical technology.
Through the agreement, MPP will further license on-exclusive sublicenses to manufacturers and diversify the manufacturing base for the supply of the drug subject to local regulation. Merck will receive no royalties for sales of the pill under the agreement for as long as COVID-19 is classified as public health emergency of international concern by the World Health Organization.