Merck has asked the FDA to authorize its antiviral Covid pill for emergency use. ScottGottliebMD weighs in: 'I think where the government misstepped is that we didn't invest enough in trying to scale up the manufacturing of therapeutics across the board.'
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 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., Dr. Mike Ryan, executive director of the World Health Organization's Health Emergencies Program, said at a news conference last week., which developed the first authorized Covid vaccine in the U.S.
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