Merck seeks FDA approval for antiviral Covid-19 pill

• The pill can cut the rate of hospitalization and death by 50%, according to a study.

• If authorized, Merck’s pill would become the first oral antiviral for COVID-19.

Merck & Co Inc said on Monday it has asked U.S. health regulators to authorize their COVID-19 pill after which it would become the first oral antiviral medication for the disease.

U.S. Food and Drug Administration could give authorization to Merck’s drug, molnuporavir, in the coming weeks.

A study showed that the drug, which can be taken at home, can cut 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.

“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” Merck Chief Executive Robert Davis said.

Also Read: Relief for COVID-19 patients as Merck pill may halve hospitalizations, deaths

Merck expects to manufacture 10 million courses of the treatment by the end of the year. The company has also secured a contract with the U.S. government to supply 1.7 million courses at $700 per course.

First oral antiviral

If the pill is authorized, it would become the first oral antiviral for COVID-19. The course of the treatment includes 40 pills—eight in a day for five days—which has to start within five days of first symptoms.

Merck said that the side effects to the pill are similar to that of a placebo, according to a study.

Also Read: Merck to acquire Acceleron for $11.5 billion in rare disease drugs push

Other drugs

Gilead Sciences Inc’s remedesivir and generic steroid dexamethasone are only given once the patient is hospitalized. Remedesivir is the only antiviral which is currently approved by the FDA.

Other drugs such as monoclonal antibody drugs from Regeneron Pharmaceuticals Inc and Eli Lilly are not widely used as it is difficult to administer them.

The shares of the company opened roughly 1% higher at $81.32.

Picture Credits: Reuters