Merck has applied for emergency use authorization from the FDA for molnupiravir, its COVID-19 antiviral pill that reduced the risk of hospitalization or death by about 50 percent in a phase 3 trial, the company announced Oct. 11.
The drugmaker asked for the drug to be authorized to treat mild to moderate COVID-19 in adults at risk of progressing to severe disease.
Merck, which is based in Kenilworth, N.J., developed molnupiravir in partnership with Miami-based Ridgeback Biotherapeutics.
"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," Wendy Holman, CEO of Ridgeback Biotherapeutics, said in a news release.
Merck expects to produce 10 million courses of treatment by the end of 2021. Each course of treatment requires patients to take 40 pills over five days.
The U.S. government signed a deal with Merck in June to purchase 1.7 million courses of molnupiravir for $1.2 billion if it's authorized by the FDA.
Merck also said Sept. 29 that molnupiravir has shown to be effective against virus variants in clinical trials.