Merck asks FDA to clear antiviral for emergency use

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

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

The drug works by inhibiting the replication of the virus inside the body. Unlike remdesivir, an intravenous drug from Gilead Sciences, molnupiravir from Merck can be taken by mouth. If approved by U.S. regulators, it would be the first pill to treat Covid, a potentially revolutionary breakthrough in the fight against the virus, which on average kills more than 1,600 Americans per day.

“The extraordinary impact of this pandemic demands that we act with
urgency, and that’s what our teams did by submitting this molnupiravir request 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 the end of the year. Merck, which developed the drug with Ridgeback Biotherapeutics, said it was actively working with regulatory agencies around the world to submit emergency use or clearance requests “in the coming months.”

The company agreed earlier this year to deliver approximately 1.7 million cycles of molnupiravir to the United States if it receives emergency use clearance or full approval from the FDA. According to the New York Times, a five-day course of medication will cost the federal government about $ 700 per patient, one-third of the current cost of monoclonal antibodies.

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

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

Other drug makers are also working on antiviral pills. The one created by Pfizer, which developed the first Covid vaccine authorized in the United States with BioNTech, could be available by the end of this year, Pfizer CEO Albert Bourla told CNBC in April.