Pfizer seek EUA for novel COVID treatment pill
pharmafile | November 19, 2021 | News story | Medical Communications |
Pfizer is seeking FDA Emergency Use Authorisation (EUA) for the novel oral antiviral, Paxlovid. The pill, if authorised, will help tackle COVID by allowing high-risk individuals infected to take an oral antiviral at home. The pill blocks the activity of an enzyme coronavirus requires to replicate.
The Phase II/III EPIC-HR clinical trial (NCT04960202) clinical trial of individuals aged 18 and over at an increased risk of developing severe COVID-19 saw an 89% reduction in the risk of COVID-19-related hospitalisation or death from any cause in patients in the treatment group, when the treatment was administered within 3 days of symptom onset.
Similar results were obtained when treatment was administered within a 5-day window. Those involved in the trial received either the antiviral pill, or a placebo. The pill was administered alongside a common HIV drug, slowing the metabolism to allow for longer drug activity to combat the virus.
Pfizer CEO Albert Bourla shared: “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 US FDA on its review of our application, along with other regulatory agencies around the world.”
Merck is commercialising an antiviral pill known as molnupiravir, to combat COVID-19. Interim analysis found that the pill reduced the risk of hospitalisation and death by 50% in adults with mild to moderate COVID. Merck submitted its application to the FDA last month for the pill to receive an EUA. The treatment offered by these drugs may help reduce the strain placed on hospitals and healthcare systems, particularly during the winter.
Ana Ovey
