Merck asks FDA to authorize antivirals for emergency use


The Merck logo on the Merck campus in Rahway, NJ.

Brendan MacDermid | Reuters

Merck He said on Monday that he requested the Food and Drug Administration to allow emergency use of experimental antivirals to treat mild to moderate Covid-19 in adults.

Requests from US pharmaceutical companies came later Phase 3 clinical trial data Released on October 1, the drug, known as molnupiravir, shows that patients newly diagnosed with Covid are less likely to be hospitalized by about 50%.

The drug works by blocking the replication of the virus in the body. Unlike the intravenous drug remdesivir from Gilead Sciences, Merck’s molnupiravir can be taken orally. If approved by US regulatory agencies, it will be the first pill to treat Covid. This is a potentially game-changing advance in the fight against the virus, killing an average of more than 1,600 Americans per day.

“The extraordinary effects of this pandemic require us to move unprecedentedly.
The urgency, and that’s what our team did by submitting this application for Molnupiravir to the FDA within 10 days of receiving the data, “Merck CEO Robert Davis said in a press release. rice field.

The pill may be available to Americans by the second half of this year. Merck, who developed the drug at Ridgeback Biotherapeutics, said he would actively work with regulators around the world to file an application for emergency use or approval “within the next few months.”

Earlier this year, the company agreed to supply the United States with approximately 1.7 million courses of molnupiravir if it received an emergency use authorization or full approval from the FDA. According to The New York Times, a five-day dosing course costs the federal government about $ 700 per patient. This is one-third of the current cost of monoclonal antibodies.

Vaccination is still the best preventive measure against the virus, but US authorities and health experts want to prevent the progression of the disease in people infected with drugs like Merck and prevent travel to hospitals.

Tablets like Merck are a kind of “Holy Grail for Treatment “Dr. Mike Ryan, Managing Director of the World Health Organization’s Health Emergency Program, said at a press conference last week.

Other pharmaceutical companies are also working on antiviral drugs. Created by PfizerPfizer CEO Albert Bourla told CNBC in April.

Merck asks FDA to authorize antivirals for emergency use

Source link Merck asks FDA to authorize antivirals for emergency use

The post Merck asks FDA to authorize antivirals for emergency use appeared first on Eminetra.


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