Merck seeks FDA authorization for antiviral drug treatment molnupiravir
Pharmaceutical giant Merck and Ridgeback are seeking authorization from the U.S. Food and Drug Administration (FDA) for the release and distribution of its new hallmark anti-COVID drug treatment.
If given the green light by the FDA, it would be the first COVID-19 treatment via oral administration with the potential to reduce symptoms of the coronavirus, as well as lower the mortality risk, in mild-to-moderate cases among adults.
“At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization, compared with 14.1% of placebo-treated patients,” a Merck press release reads.
“We are grateful to the clinical investigators and patients who have helped bring us to this important milestone. Without their significant contributions, today’s achievement would not be possible. The submission to the FDA is a critical step towards making molnupiravir available to people who may benefit from an oral antiviral medicine that can be taken at home shortly after diagnosis with COVID-19,” the press release also states.
“We are pleased to partner with Merck and regulatory authorities to help provide molnupiravir to the people who need it here in the U.S. and around the world.”
Molnupiravir is said to work by inhibiting the replication of SARS-Cov-2, thus reducing the severity of symptoms.
The FDA is set to review its authorization request within the next few weeks.