Merck, Ridgeback get the second FDA nod for COVID antiviral

Dec. 27, 2021

One day after Pfizer's Paxlovid got the FDA green light as the first oral COVID-19 treatment, Merck & Co. and Ridgeback Biotherapuetics’ molnupiravir was granted emergency use authorization as the second antiviral pill in the U.S.

On Dec. 23, the FDA issued an EUA for Merck’s molnupiravir for the treatment of mild-to-moderate COVID-19 in adults who test positive and are at high risk for progression to severe COVID-19. Molnupiravir, which works by introducing errors into the SARS-CoV-2 virus’ genetic code which prevents the virus from further replicating, is administered as four 200 milligram capsules taken orally every 12 hours for five days, for a total of 40 capsules.

Due to concerns about the potential side effects, including affecting bone and cartilage growth, the agency has restricted molnupiravir use to adults and only in scenarios in which other authorized treatments, including monoclonal antibodies, are inaccessible or are not “clinically appropriate.”

Clinical trials found that molnupiravir reduced the risk of hospitalization and death among high-risk COVID patients by 30%. Final trial data showed that Pfizer's Paxlovid reduced risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo.

The United States has agreed to purchase about 3.1 million courses of Merck's molnupiravir for $2.2 billion.