Merck seeks U.S. approval for COVID pill
Move puts drug one step closer to becoming first oral antiviral treatment
Merck & Co. and its partner Ridgeback Biotherapeutics LP are seeking 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 U.S. 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 an interim analysis of clinical trial data found 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 Merck chief executive officer Robert M. Davis, who took the helm from Kenneth Frazier in July.
Molnupiravir can be given to patients at home, unlike Gilead Sciences Inc.’s antiviral remdesivir and monoclonal antibody therapies that are administered via intravenous infusion usually in hospitals or clinics. Treating COVID patients at home averts the risk they’ll transmit the virus to medical staff and other patients.
Nicholas Kartsonis, senior vice-president of clinical research for infectious diseases and vaccines at Merck Research Labs, said he’s encouraged by the safety profile of the pill.
“We don’t see a lot of specific adverse experiences of concern,”
he said, noting Merck has shared robust data on side effects with U.S. regulators.
Asked if Merck anticipated an authorization before a potential holiday surge in infections, Kartsonis said he hopes to see clearance by Halloween.
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.
The Kenilworth, N.J.-based drugmaker agreed in June to a $1.2-billion supply deal to provide the U.S. government 1.7 million courses of treatment once the drug gains FDA authorization or approval.