Merck asks for first US authorisation of anti-coronavirus tablet

• An authorisation from the US Food and Drug Administration could help change the clinical management of COVID-19.
• The treatment, molnupiravir, cut the rate of hospitalisation and death by 50% in a trial of mild-to-moderately ill patients.
• Merck holds a US government contract to supply 1.7 million courses for $700 per course.

Merck & Co Inc said Monday it has sought US authorisation for emergency use of 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 the 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% 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 for $700 per course. Merck expects to produce 10 million courses of 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.

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.