WASHINGTON (AP) — Pfizer is submitting its experimental pill for COVID-19 for U.S. authorization, setting the stage for a likely launch of the promising therapy in the coming weeks.
The company’s antiviral, which will be sold as Paxlovid, is one of a handful of pills that have recently been shown to significantly cut hospitalizations and deaths among people infected with COVID-19.
If authorized by the Food and Drug Administration (FDA), it could be a major step toward managing the pandemic, allowing patients to treat themselves at home.
Pfizer says Paxlovid would be the first oral antiviral of its kind, a 3CL protease inhibitor specifically designed to combat COVID-19 that could be prescribed as an at-home treatment to high-risk patients at the first sign of infection.
Pfizer says it’s seeking emergency use authorization (EUA) for Paxlovid based on positive results from an EPIC-HR interim analysis, which enrolled non-hospitalized adults with confirmed COVID-19 who were at increased risk of progressing to severe illness.
The data demonstrated an 89% reduction in risk of COVID-19-related hospitalization or death from any cause in patients treated with Paxlovid compared to placebo within three days of symptom onset, with no deaths in the treatment group, according to Pfizer. Similar results were reportedly seen within five days of symptom onset.
Albert Bo, the chairman and CEO of Pfizer, noted in the announcement of the EUA submission that 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,” said Bourla. “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.”
Next, FDA regulators will scrutinize company data on the safety and effectiveness of the drug before making a decision.
