Merck & Co. and its partner Ridgeback Biotherapeutics LP sought emergency use authorization in the U.S. for molnupiravir, moving the pill closer to becoming the first oral antiviral treatment for COVID-19.
An application was submitted with the Food and Drug Administration for molnupiravir to treat mild-to-moderate COVID-19 in adults at risk of developing a severe illness that may require hospitalization, the companies said in a statement Monday. Submissions to regulatory authorities worldwide are expected in the coming months after interim analysis of clinical trial data found that it cut the risk of hospitalization for such patients by half.
“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” said Robert M. Davis, Merck’s chief executive officer and president. “We look forward to working with the FDA on its review of our application, and to working with other regulatory agencies as we do everything we can to bring molnupiravir to patients around the world as quickly as possible.”
Molnupiravir can be given to patients at home, unlike Gilead Sciences Inc.’s antiviral remdesivir and monoclonal antibody therapies, which are administered via an intravenous infusion usually in a hospital or a clinic. Treating COVID-19 patients at home avoids the risk of them transmitting the virus to medical staff and other patients.
Merck shares traded 1% lower in pre-market trading at 6:35 a.m. in New York, erasing part of an earlier decline.
A five-day course of molnupiravir will cost about $700 per patient — a third of the amount of a monoclonal antibody treatment, according to the New York Times. Safe, well-tolerated, affordable and easy-to-administer antivirals are ideal treatments because they directly counter the virus, limiting its damage to the body and the duration of illness. Steroids and blood-thinners that have been shown to improve survival in hospitalized patients don’t directly fight the virus; rather they prevent a worsening of COVID symptoms.
Merck reiterated that it expects to make 10 million treatment courses by the end of 2021, with more doses slated for production in 2022. The drugmaker agreed in June to a $1.2 billion supply deal with the U.S. government under which it will provide 1.7 million courses of the treatment once the drug gains emergency use authorization or approval from the FDA.