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The Financial Express

Merck seeks first US authorisation for COVID-19 pill

| Updated: October 15, 2021 19:08:24


Merck seeks first US authorisation for COVID-19 pill

American pharmaceutical company Merck & Co Inc has applied for US emergency use authorisation 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 authorisation from the US Food and Drug Administration could help change clinical management of COVID-19 as the pill can be taken at home, according to a Reuters report published on Monday.

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

It has also agreed to licence 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 Inc's infused antiviral remdesivir is generally given only once a patient is hospitalised.

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 per cent higher before paring some gains to trade at $81.32

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