Merck requesting US authorization for the first COVID-19 pill
Merck & Co Inc said on Monday it has applied for U.S. emergency use authorization for its drug to treat mild-to-moderate patients of COVID-19, putting it on course to become the first oral antiviral medication for the disease.
An authorization from the U.S. Food and Drug Administration could help change clinical management of COVID-19 as the pill can be taken at home.
The treatment, molnupiravir, cut the rate of hospitalization and death by 50% in a trial of mild-to-moderately ill patients who had at least one risk factor for the disease, according to data released earlier this month.
The interim efficacy data on the drug, developed with Ridgeback Biotherapeutics, had heavily dented the shares of COVID-19 vaccine makers and set off a scramble among nations, including Malaysia, South Korea and Singapore, to sign a supply deal with Merck.
Members of a COVID medical team transport a coronavirus disease (COVID-19) positive patient to their room on the COVID medical unit at Sarasota Memorial Hospital in Sarasota, Florida, U.S., September 21, 2021. REUTERS/Shannon Stapleton/File Photo
The drugmaker has a U.S. government contract to supply 1.7 million courses at a price of $700 per course. Merck expects to produce 10 million courses of the treatment by the end of 2021.
It has also agreed to license the drug to several India-based generic drugmakers, which are expected to supply the treatment to more than 100 low- and middle-income countries.
Alisson Argueta, 8, is given a coronavirus disease (COVID-19) test at a back-to-school clinic in South Gate, Los Angeles, California, U.S., August 12, 2021. REUTERS/Lucy Nicholson/File Photo
Gilead Sciences Inc’s infused antiviral remdesivir is generally given only once a patient is hospitalized.
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Monoclonal antibody drugs from Regeneron Pharmaceuticals Inc and Eli Lilly, which are typically infused as well, have so far seen only limited use due to the difficulty in administering them.
Merck’s shares opened roughly 1% higher before paring some gains to trade at $81.32.
(Reporting by Manas Mishra and Leroy Leo in Bengaluru; Editing by Arun Koyyur)
