Merck applies for US emergency authorisation of Covid-19 pill

WASHINGTON (REUTERS) - Merck & Co Inc 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 or 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, which has been 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, known as MSD outside the United States and Canada,  has a US government contract to supply 1.7 million courses at a price of US$700 (S$947.87 million) 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. 

Existing drugs from Gilead Sciences Inc’s infused antiviral remdesivir and generic steroid dexamethasone are 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.