Merck Seeks First US Authorisation for Covid Pill
Merck & Co Inc said Monday that it has applied for U.S. emergency use authorization for its drug to treat mild to moderate COVID-19 patients, putting it on track to become the first oral antiviral drug for the disease.
An authorization 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, reduced the rate of hospitalization 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 published earlier this month.
Interim efficacy data for the drug, developed with Ridgeback Biotherapeutics, had greatly affected the actions of COVID-19 vaccine manufacturers and sparked a fight among nations, including Malaysia, South Korea, and Singapore, to sign a supply agreement. with Merck.
The drugmaker has a contract with the US government to supply 1.7 million courses at a price of $ 700 per course. Merck expects to produce 10 million cycles of treatment by the end of 2021.
It also agreed to license the drug to several Indian-based generic drug makers, which are expected to supply the treatment to more than 100 low- and middle-income countries.
Gilead Sciences Inc (GILD.O) infused antiviral redeliver is generally administered only once the patient is hospitalized The monoclonal antibody drugs from Regeneron Pharmaceuticals Inc (REGN.O) and Eli Lilly (LLY.N), which are also commonly infused, have so far only seen limited use due to difficulty in administering them Merck shares opened about 1% higher before cutting some gains to trade at $ 81.32.