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

Merck & Co Inc. said on Monday it has applied for U.S. emergency use authorization for its tablet 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 per cent 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.

The drugmaker has a U.S. government contract to supply 1.7 million courses at a price of US$700 per course. Merck expects to produce 10 million courses of the treatment by the end of 2021.

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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.

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Existing drugs from Gilead Sciences Inc’s infused antiviral remdesivir and generic steroid dexamethasone are generally given only once a patient is hospitalized.

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.

In a statement to Global News, a Merck spokesperson said the company started a rolling submission to Health Canada for its COVID-19 treatment.

“Health Canada will make a decision only when all necessary evidence has been submitted and reviewed. While a supply agreement is not yet in place, conversations are actively taking place with the government,” the spokesperson said.

“We remain committed to working with the government to ensure Canadians will have access to our medicine should it receive market authorization by Health Canada.”