Merck asks FDA to authorize antiviral for emergency use

Merck said Monday it has asked the Food and Drug Administration to authorize emergency use of its experimental antiviral pill to treat mild to moderate Covid-19 in adults.

The U.S. drugmaker’s request came after phase three clinical trial data released on Oct. 1 showed that the medication – known as molnupiravir – reduced the chances that patients newly diagnosed with Covid would be hospitalized by about 50%.

The drug works by inhibiting the replication of the virus inside the body. Unlike Gilead Sciences’ intravenous drug remdesivir, Merck’s molnupiravir can be taken by mouth. If approved by U.S. regulators, it would be the first pill to treat Covid, a potentially game-changing advancement in the fight against the virus, which is killing an average of more than 1,600 Americans per day.

“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 CEO Robert Davis said in a press release.

The pill could be available to Americans by late this year. Merck, which developed the drug with Ridgeback Biotherapeutics, said it is actively working with regulatory agencies worldwide to submit applications for emergency use or authorization “in the coming months.”

The company agreed earlier this year to supply the U.S. with around 1.7 million courses of molnupiravir if it receives emergency use authorization or full approval from the FDA. According to The New York Times, a five-day course of the medication will cost the federal government about $700 per patient, a third of the current cost of monoclonal antibodies.

While vaccinations remain the best form of protection against the virus, U.S. officials and health experts hope a pill like Merck’s will keep the disease from progressing in those who do get infected and prevent trips to the hospital.

Pills like Merck’s are considered a sort of “holy grail” for treatments, Dr. Mike Ryan, executive director of the World Health Organization’s Health Emergencies Program, said at a press conference last week.

Other drugmakers are also working on antiviral pills. One created by Pfizer, which developed the first authorized Covid vaccine in the U.S. with BioNTech, could be available by the end of this year, Pfizer CEO Albert Bourla told CNBC in April.