Pfizer Inc has announced that it is seeking Emergency Use Authorization (EUA) of its investigational oral antiviral tablet PAXLOVID which will be able to treat Covid-19 in the early stages of the deadly virus. It will be used for mild to moderate treatment of patients suffering from Coronavirus and will help decrease the risk of hospitalization or death.
This submission to the U.S. Food and Drug Administration (FDA) includes clinical data from the Phase 2/3 EPIC-HR interim analysis. Rolling submission of non-clinical data for PAXLOVID was initiated with the U.S. FDA in October 2021.
If authorized or approved, PAXLOVID would be the first oral antiviral of its kind, a 3CL protease inhibitor specifically designed to combat SARS-CoV-2 that could be prescribed as an at-home treatment to high-risk patients at the first sign of infection.
“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 U.S. FDA on its review of our application, along with other regulatory agencies around the world," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.
“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. The overwhelming efficacy achieved in our recent clinical study of PAXLOVID, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19," she added.
Pfizer plans to apply for a European authorisation of its experimental antiviral pill to treat Covid-19 on Friday, German weekly Wirtschaftswoche said, citing sources close to the European Medicines Agency (EMA) and the company.
Pfizer is seeking EUA for PAXLOVID based on positive results from the EPIC-HR interim analysis, which enrolled non-hospitalized adults aged 18 and older with confirmed COVID-19 who are at increased risk of progressing to severe illness.
According to a BBC report, the PAXLOVID pill to treat Covid developed by the US company Pfizer cuts the risk of hospitalisation or death by 89% in vulnerable adults, clinical trial results suggest.
(with inputs from sources)