Merck asks FDA to authorize antiviral Covid tablet for emergency use

Merck stated Monday it requested the Meals and Drug Administration to authorize emergency use of its experimental antiviral tablet to deal with mild-to-moderate Covid-19 in adults.

The U.S. drugmaker’s request got here after phase three clinical trial data launched on October 1 confirmed the remedy – often called molnupiravir – decreased the possibilities that sufferers newly identified with Covid could be hospitalized by about 50%.

The drug works by inhibiting the replication of the virus contained in the physique. In contrast to Gilead Sciences’ intravenous drug remdesivir, Merck’s molnupiravir may be taken by mouth. If authorized by U.S. regulators, it will be the primary tablet to deal with Covid, a probably game-changing development within the battle in opposition to the virus, which is killing a median of greater than 1,600 People per day.

“The extraordinary affect of this pandemic calls for that we transfer with unprecedented
urgency, and that’s what our groups have completed by submitting this utility for molnupiravir to the FDA inside 10 days of receiving the info,” Merck CEO Robert Davis stated in a press launch.

The tablet may very well be out there to People by late this 12 months. Merck, which developed the drug with Ridgeback Biotherapeutics, stated it’s actively working with regulatory businesses worldwide to submit purposes for emergency use or authorization “within the coming months.”

The corporate agreed earlier this 12 months to provide the U.S. with round 1.7 million programs of molnupiravir if it receives emergency use authorization or full approval from the FDA. In response to The New York Instances, a five-day course of the remedy will value the federal authorities about $700 per affected person, a 3rd of the present value of monoclonal antibodies.

Whereas vaccinations stay the very best type of safety in opposition to the virus, U.S. officers and well being specialists hope a tablet like Merck’s will maintain the illness from progressing in those that do get contaminated and forestall journeys to the hospital.

Drugs like Merck’s are thought-about a type of “holy grail” for treatments, Dr. Mike Ryan, govt director of the World Well being Group’s Well being Emergencies Program, stated at a press convention final week.

Different drugmakers are additionally engaged on antiviral drugs. One created by Pfizer, which developed the primary licensed Covid vaccine within the U.S. with BioNTech, may very well be out there by the top of this 12 months, Pfizer CEO Albert Bourla advised CNBC in April.