Pfizer is formally petitioning the Food and Drug Administration for emergency use authorization of its antiviral Covid-19 pill, two weeks after reporting trial results showing the treatment cuts the risk of hospitalization and death from the disease by 89 percent.
The positive results from an interim analysis of its Phase II/III trial data — focused on more than 770 high-risk, infected adults who were treated with the drug or a placebo within three days of the onset of symptoms — convinced the company to halt enrollment of new participants due to “the overwhelming efficacy demonstrated in these results,” Pfizer said at the time.
“With more than 5 million deaths and countless lives impacted by this devastating disease globally, there is an urgent need for life-saving treatment options,” CEO Albert Bourla said Tuesday. “We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients.”
The pill, called Paxlovid, was slightly less effective when given up to five days after patients presented symptoms, Pfizer said.
Availability of an oral medication that can treat Covid symptoms while keeping most patients out of the hospital could be a game changer for the course of the pandemic. Pills are easier to manufacture and distribute than therapies like monoclonal antibodies, which are administered by health care providers.
FDA is also considering an EUA application from Merck for an antiviral drug, molnupiravir, creating the prospect of two at-home coronavirus treatments being available, potentially in a matter of weeks.
What’s next: FDA’s independent advisers will meet on Nov. 30 to consider Merck’s application.