Benzinga | Dec 23, 2021 09:41AM EST

FDA Approves Another COVID-19 Antiviral Pill, This Time From Merck

The FDA has approved Merck & Co Inc's (NYSE:MRK) molnupiravir to treat mild-to-moderate COVID-19 in adults.

* Molnupiravir is not authorized for use in patients younger than 18 years of age because molnupiravir may affect bone and cartilage growth.

* The agency approved Pfizer Inc's (NYSE:PFE) Paxlovid for patients aged 12 years who are at high risk for progression to severe COVID-19.

* Molnupiravir is a medication that works by introducing errors into the SARS-CoV-2 virus' genetic code, which prevents the virus from further replicating.

* The treatment is administered as four 200 milligram capsules taken orally every 12 hours for five days. It is not authorized for use for longer than five consecutive days.

* The primary data supporting this EUA for molnupiravir are from the MOVe-OUT trial.

* Of the 709 people who received molnupiravir, 6.8% were hospitalized or died compared to 9.7% of the 699 people who received a placebo.

* Of the people who received molnupiravir, one died during the follow-up period compared to nine placebo patients.

* Side effects observed in the trial included diarrhea, nausea, and dizziness.

* Also, molnupiravir is not recommended during pregnancy, as it may cause fetal harm.

* Price Action: MRK shares are down 0.25% at $75.97 during the market session on the last check Thursday.