Merck Seeks Emergency Use Authorization for Covid-19 Pill
(Bloomberg) -- 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 an interim analysis of clinical trial data found it cut the risk of hospitalization for such patients by half.
Merck shares were little changed at 10 a.m. in New York on Monday.
“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.
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.
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 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.
Merck reiterated that it expects to make 10 million treatment courses, or 400 million capsules, by the end of 2021. “Substantially more will be produced in 2022,” said Paul Schaper, Merck’s executive director of global pharmaceutical public policy, in an interview.
The Kenilworth, New Jersey-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. Looking globally, Schaper said he anticipates “a number of other announcements being made over the course of the next several weeks.”
Merck will continue to aim to make voluntary licenses available to third-party generic drug manufacturers so that the pill can be produced at scale for low and middle-income countries, Schaper said.
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