Merck's oral new crown drug Molnupiravir receives FDA emergency use authorization

On December 23, Merck/Ridgeback announced that the oral new crown drug Molnupiravir (MK-4482/EIDD-2801) has received emergency use authorization from the US FDA for the treatment of adult patients with mild to moderate COVID-19

It is worth noting that on November 4, 2021, Merck/Ridgeback announced that the British Medicines and Healthcare Products Regulatory Agency has approved the marketing of molnupiravir in the UK for the treatment of severe and mild to moderate COVID-19 adult patients with a higher risk of hospitalization

This time, Molnupiravir has been authorized by the FDA for emergency use, mainly based on the positive results of the interim analysis of the Phase III MOVe-OUT study and the recently updated data

On November 26, additional analysis data for all subjects (n=1433) showed that molnupiravir reduced the risk of hospitalization or death from 9.

On November 30, the US FDA Antimicrobial Drug Advisory Committee (AMDAC) actively supported the emergency use authorization (EUA) application of Molnupiravir with 13 votes in favor and 10 votes against it

In addition, Merck also announced a few days ago that it will share its antiviral drug Molnupiravir for the treatment of new crowns with developing countries to expand the use of this promising treatment method

Background information

Molnupiravir (MK-4482, EIDD-2801) is a potent ribonucleoside analogue in oral form under research that can inhibit the replication of SARS-CoV-2 (the causative agent of the new coronavirus)

Molnupiravir was developed by the Drug Innovation Center (or DRIVE), a non-profit biotechnology company wholly-owned by Emory University.