The U.S. Food & Drug Administration has granted Emergency Use Authorization for Merck‘s molnupiravir, an antiviral pill for COVID-19, for certain high-risk adult patients.
The Kenilworth-based company developed the druge with Ridgeback Biotherapeutics.
Molnupiravir cut the risk of hospitalization and death in high-risk patients by 30%.
“The FDA Emergency Use Authorization of molnupiravir is an important milestone in the fight against COVID-19, and adds to Merck’s legacy of bringing forward innovative medicines that both address the world’s greatest health threats and help save lives,” said Robert Davis, CEO and president, Merck.
The FDA authorized the five-day course of treatment in patients 18 and older who are at high risk of severe COVID-19 and “for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.”
The recommended dose for molnupiravir is 800 mg (four 200 mg capsules) taken orally every 12 hours for five days, with or without food.
Merck anticipates that it will begin shipping molnupiravir to AmerisourceBergen in Kearny, the sole distributor of molnupiravir, within days.
As per a previously announced procurement agreement with the U.S. government, Merck will supply approximately 3.1 million courses of molnupiravir to the U.S. government upon the EUA.