Antivirals are coming.
A day after the U.K. approved MSD/Ridgeback’s molnupiravir to treat vulnerable people infected with COVID-19, Pfizer on Friday reported 89 percent reduced risk of hospitalization or death with its antiviral candidate.
An interim analysis showed that compared with a placebo its antiviral therapy, named Paxlovid, significantly improved the chance of survival among non-hospitalized high-risk adults with COVID-19.
Overall, there were no deaths through day 28 among patients randomized to receive the oral antiviral therapy, compared with 10 deaths in patients who received the placebo.
Pfizer CEO Albert Bourla described the results as “a real game-changer” in the pandemic. He said that Paxlovid — which combines an investigational SARS-CoV-2 protease inhibitor with an existing HIV antiviral therapy — “has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of 10 hospitalizations.”
Pfizer compared treating people within three days of symptoms and within five days of symptoms and found that earlier treatment had better results.
Among those treated within three days, there were three hospitalizations with no deaths out of 389 patients; versus 27 hospitalizations with seven subsequent deaths among 385 patients who received placebo.
Among those treated within five days, there were six hospitalizations with no deaths from 607 patients treated with the antiviral therapy; compared to 41 hospitalizations with 10 subsequent deaths from 612 patient given placebo.
Early analysis suggests the drug had a favorable safety profile with more people reporting side effects with the placebo than the antiviral.
The study results will be submitted first to the U.S. Food and Drug Authority for emergency use authorization.
The U.K. has a contract for 250,000 courses of Pfizer’s antiviral therapy, previously known as PF-07321332/ritonavir, as well as 480,000 treatment courses of MSD/Ridgeback’s molnupiravr.