Pfizer Inc (NYSE:PFE)‘s novel oral antiviral candidate Paxlovid has been shown to significantly reduce the risk of hospitalisation or death from COVID-19.
In a phase 2/3 study of non-hospitalised adult patients with COVID-19 who were at high risk of progressing to severe illness, the interim analysis showed an 89% reduction in risk of COVID-19-related hospitalisation or death from any cause compared to placebo in patients treated within three days of symptom onset, Pfizer said in a statement.
In the overall study population through day 28, no deaths were reported in patients who received Paxlovid, compared to 10 deaths in patients who received placebo, it added.
The US pharmaceuticals company said it plans to submit the study data to the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA) as soon as possible.
The news follows yesterday’s announcement that the UK medicines agency MHRA has approved Merck’s anti-coronavirus treatment molnupiravir for use in treating people with mild to moderate COVID-19 at risk of developing a severe illness such as heart disease.
“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 authorised 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 hospitalisations,” said Albert Bourla, chairman and chief executive officer of Pfizer.
If approved, Paxlovid would be the first oral antiviral of its kind, a specifically designed SARS-CoV-2-3CL protease inhibitor, Pfizer said. Subject to approval, it could be prescribed as an at-home treatment to help reduce illness severity, hospitalizations, and deaths, as well as reduce the probability of infection following exposure, among adults.