Merck to Seek FDA OK for Its COVID Pill After Trial Stopped Early
Merck & Co Inc's experimental oral drug for COVID-19, molnupiravir, reduced by around 50% the chance of hospitalization or death for patients at risk of severe disease, according to interim clinical trial results announced on Friday.
Merck and partner Ridgeback Biotherapeutics plan to seek U.S. emergency use authorization for the pill as soon as possible, and to submit applications to regulatory agencies worldwide. Due to the positive results, the Phase 3 trial is being stopped early at the recommendation of outside monitors.
"This is going to change the dialogue around how to manage COVID-19," Robert Davis, Merck's chief executive officer, told Reuters.
If authorized, molnupiravir, which is designed to introduce errors into the genetic code of the virus, would be the first oral antiviral medication for COVID-19.
Scientists welcomed the potential new treatment to help prevent serious illness from the virus, which has killed almost 5 million people around the world.
"The availability of a well-tolerated, effective oral antiviral will be particularly useful in supplementing vaccination as a means to reduce the proportion of patients needing hospital care," Professor Penny Ward, visiting professor in pharmaceutical medicine at King’s College London.