Trials of a new oral antiviral pill treatment for COVID-19 developed by Pfizer have shown that the drug is 89 percent effective at reducing the risk of hospitalization when taken within three days of illness onset.
In a press release issued Friday, Pfizer said that less than 1 percent of patients who received the treatment – named Paxlovid – were hospitalized after 28 days, compared to 7 percent of patients who received a placebo. Of the 27 people hospitalized who received the placebo, seven died.
Similar results were found even when patients were treated within five days of symptom onset, said Pfizer.
In fact, the treatment was so successful that the U.S. Food and Drug Administration and an independent data monitoring committee recommended that Pfizer cease any further enrollment in the study, which began in July. Primary analysis of the interim data covered 1,219 adult patients who were enrolled by Sept.
29.
The company plans to submit the data as part of its ongoing rolling submission to the U.S. FDA for Emergency Use Authorization (EUA) as soon as possible.
“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic. 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,” said Albert Bourla, CEO and chairman of Pfizer.
If approved, Paxlovid would be the first oral antiviral of its kind, Pfizer said. It is a specifically designed SARS-CoV-2-3CL protease inhibitor.
Pfizer said the medication’s PF-07321332 molecule as an investigational SARS-CoV-2 protease inhibitor antiviral therapy that works by blocking an enzyme that the novel coronavirus needs to replicate. It is designed to be administered orally so that it can be prescribed at the first sign of infection or at first awareness of an exposure.
“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,” said Chief Scientific Officer and President for Worldwide Research, Development and Medical of Pfizer, Mikael Dolsten, MD, PhD.
Paxlovid also includes a low dose of ritonavir to help slow the breakdown of PF-07321332 so it can remain active in the body for a longer period of time at higher concentrations. Ritonavir is a protease inhibitor often administered with other medications to help treat HIV infection.
Earlier this week, regulators in England approved another orally-administered COVID-19 treatment, called molnupiravir and marketed in the U.K. as Lagevrio, for use in people age 60 and older or people with a high-risk condition. This pill was developed by the U.S.-based company Merck.
According to NBC News, advisors to the FDA are scheduled to meet Nov. 30 to discuss emergency authorization of the Merck pill. The U.S. government will cover the costs of both medications, which are estimated at $700 per course of treatment, said the outlet.
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