Merck’s antiviral pill ‘Molnupiravir’ has received approval for emergency use from the U.S. Food and Drug Administration. Widely hailed as a gamechanger in the fight against COVID-19, it is expected to reduce deaths due to the pandemic in the coming days.
The FDA announced on Thursday that the drug can now be prescribed to adults “who are at high risk for progression to severe COVID-19, including hospitalization or death”. Treatment with Molnupiravir will need to follow a strict regimen, with 4 pills taken every 12 hours for 5 consecutive days.
Molnupiravir works by introducing errors into the genetic code of SARS-CoV-2, preventing the virus from replicating. Phase 3 trials of the drug done in patients with mild-to-moderate COVID-19 had found that it reduced the risk of hospitalization or death by approximately 50%.
“At the Interim Analysis, 7.3 Percent of Patients Who Received Molnupiravir Were Hospitalized Through Day 29, Compared With 14.1 Percent of Placebo-Treated Patients Who were Hospitalized or Died.”
Press release by Merck
Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research said that “Molnupiravir is limited to situations where other FDA-authorized treatments for COVID-19 are inaccessible or are not clinically appropriate”.
The FDA has not authorized the use of Molnupiravir in patients younger than 18 years of age due to the possibility that it may affect bone and cartilage growth. It is also not recommended for use in pregnant women in light of evidence from animal studies that it may cause fetal harm. The FDA said that a healthcare provider can however administer the drug if it deems that the benefits outweigh the risks for that individual patient, and after it has obtained informed consent from the patient.
Besides the US, the UK and Bangladesh have approved Molnupiravir for emergency use.
