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Merck seeks first US authorisation for COVID-19 pill

Merck seeks first US authorisation for COVID-19 pill

FILE PHOTO: The Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey, U.S., July 12, 2018. REUTERS/Brendan McDermid

Merck & Co said on Monday (Oct 11) it has applied for US emergency use authorisation 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 authorisation from the US 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 hospitalisation 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 company is known as MSD outside the US and Canada.

The drugmaker has a US 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.

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.

Gilead Sciences' infused antiviral remdesivir is generally given only once a patient is hospitalised.

Monoclonal antibody drugs from Regeneron Pharmaceuticals 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 per cent higher before paring some gains to trade at US$81.32.
 

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. 

Existing drugs include Gilead Sciences Inc's infused antiviral remdesivir and generic steroid dexamethasone, both of which are generally only given once a patient has already been hospitalised.

Monoclonal antibody drugs have so far seen only limited uptake due to the difficulty in their administration.

 

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Source: Reuters/gs

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