Drug maker Merck on Monday said it requested emergency authorization from the US Food and Drug Administration for its experimental antiviral pill for COVID-19, known as molnupiravir. The pill, which was developed by Merck and Ridgeback Biotherapeutics, is intended to treat in adults at risk of developing a more severe case or needing hospitalization.
“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,” said Wendy Holman, CEO of Ridgeback Biotherapeutics, in a release.
If authorized, molnupiravir would be the first antiviral pill for treating COVID-19. The other antiviral drug approved by the FDA to treat COVID-19 is remdesivir, which must be administered by IV or injection and which is only for people hospitalized with COVID-19. The FDA has also authorized monoclonal antibody therapy, which is free and available to Americans at high risk of severe COVID-19. The antibody treatment is usually given intravenously and can be administered outside a hospital, but some health care advocates think it’s been underutilized or poorly distributed.
Earlier this month, Merck said molnupiravir reduces the risk of hospitalization or death by roughly half. Early results for molnupiravir showed that high-risk adults who took the pill within five days of developing COVID-19 symptoms were about 50% less likely to be hospitalized or die, compared with patients who received a placebo (7.3% vs. 14.1%), according to Merck. The clinical trial included 775 adults with mild to moderate COVID-19 who also had at least one risk factor, such as obesity or heart disease. The drug maker also reported that adverse reactions in people who took the pill were similar to those in people who took a placebo pill.
If Merck’s pill becomes available, it could be the breakthrough in treatment that many have been hoping for. The pandemic has killed more than 4.8 million people worldwide, including over 700,000 in the US.
A press officer for the FDA said the agency can’t disclose information about unapproved products but said the FDA is “committed to quickly and thoroughly reviewing all submitted applications … to speed patient access to medicines to prevent or treat COVID-19 provided they meet the agency’s rigorous standards.”