Merck asks FDA to authorize emergency use of antiviral drugs

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Merck logo on the Merck campus in Rawai, New Jersey.

Bren Dank Demead | Reuters

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

The US drugmaker’s request was made after the Phase III clinical trial data released on October 1 showed that this drug (called monelavir) reduced the chance of hospitalization for newly diagnosed Covid patients by approximately 50% of.

The drug works by inhibiting the replication of viruses in the body. Unlike Gilead Sciences’ intravenous drug Remdesivir, Merck’s monelavir can be taken orally. If approved by US regulators, this will be the first pill to treat Covid. This is a potentially game-changing advancement in the fight against this virus, which kills an average of more than 1,600 Americans every day.

“The extraordinary impact of this pandemic requires us to act in an unprecedented way
Urgency, this is what our team did and submitted an application for monelavir to the FDA within 10 days of receiving the data,” Merck CEO Robert Davis said in a press release.

This pill may be available to Americans later this year. Merck, which co-developed the drug with Ridgeback Biotherapeutics, said it is actively working with global regulatory agencies to submit emergency use or authorization applications “in the coming months.”

The company agreed earlier this year that if it obtains emergency use authorization or full approval from the FDA, it will supply about 1.7 million monopivir treatment courses to the United States. According to the New York Times, a five-day course of medication will cost the federal government approximately US$700 per patient, which is one-third of the current cost of monoclonal antibodies.

Although vaccination is still the best form of defense against the virus, US officials and health experts hope that pills like Merck will prevent the disease progression of infected people and prevent them from going to the hospital.

Dr. Mike Ryan, Executive Director of the World Health Organization’s Health Emergency Program, said at a press conference last week that pills like Merck are considered the “Holy Grail” of treatment.

Other drugmakers are also studying antiviral pills. Pfizer CEO Albert Bourla told CNBC in April that a vaccine developed by Pfizer may be available at the end of this year. The vaccine and BioNTech developed the first vaccine in the United States. Authorized Covid vaccine.

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