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

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

The FDA has approved Merck & Co Inc's 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 PFE Paxlovid for patients aged 12 years who are at high risk for progression to severe COVID-19.
  • Molnupiravir, developed in collaboration with Ridgeback Biotherapeutics, 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.

Posted In: BriefsCOVID-19 CoronavirusBiotechNewsHealth CareFDAGeneral