Merck asks U.S. FDA for emergency stamp for COVID-19 tablet

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Merck & Co Inc said on Monday it has applied for US emergency use authorization for its tablet to treat mild to moderate patients with COVID-19, making it the first oral antiviral drug for the disease.

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An authorization from the US Food and Drug Administration could help transform the clinical management of COVID-19 as the pill can be taken at home.

According to data released earlier this month, the treatment, molnupiravir, cut hospitalization and death rates by 50 percent in trials of mild to moderately ill patients who had at least one risk factor for the disease. Was.

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Interim efficacy data on a drug developed with Ridgeback Biotherapeutics heavily hurt stocks of COVID-19 vaccine makers and triggered a scuffle between countries including Malaysia, South Korea and Singapore to sign supply agreements with Merck.

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The drugmaker has a US government contract to supply 1.7 million courses at a cost of US$700 per course. Merck expects to have 10 million courses of treatment ready by the end of 2021.

It has also agreed to license the drug to several India-based generic drug makers, who are expected to supply the treatment to more than 100 low and middle-income countries.

The current drugs, Gilead Sciences Inc.’s infused antiviral remdesivir and the generic steroid dexamethasone, are usually given only after a patient is hospitalized.

Regeneron Pharmaceuticals Inc. and Eli Lilly’s monoclonal antibody drugs, which are also commonly used, have so far seen only limited use due to the difficulty of administering them.

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