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October 12, 2021: -On Monday, Merck said it 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 request of a U.S. drugmaker came after phase three clinical trial data released on October 1 showed the medication known as molnupiravir reduced the chances that patients diagnosed with Covid would be hospitalized by about 50%.
The drug works after inhibiting of replication of the virus inside the body. Unlike Gilead Sciences’ intravenous drug redeliver, Merck’s molnupiravir can be taken by mouth. If U.S. regulators approve it, it would be the first pill to treat Covid, a potentially game-changing advancement in the fight against the virus, killing an average of over 1,600 Americans each day.
“The extraordinary impact of this pandemic is demanding that we move with unprecedented urgency, and that is what our teams did by submitting this application for molnupiravir to the FDA within ten days of receiving the data,” Merck CEO Robert Davis said.
The pill could be available to Americans. Merck, which developed the drug with Ridgeback Biotherapeutics, said it works actively with regulatory agencies worldwide to submit applications for emergency use or authorization “in the future months.”
The company is agreeing earlier this year to supply the U.S. with around 1.7 million courses of molnupiravir if receiving emergency use authorization or full approval from the FDA. According to The New York Times, five days 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 such as Merck’s will keep the disease from progressing in those who get infected and prevent trips to the hospital.
Pills such as 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 in the previous week.
Other drugmakers are working on antiviral pills. One created by Pfizer, developing the first authorized Covid vaccine in the U.S. with BioNTech, could be available by this year’s end, Pfizer CEO Albert Bourla told CNBC in April.
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