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Merck asks FDA to authorize antiviral for emergency use

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Merck’s logo on the Merck campus at Rahway in New Jersey.

Brendan McDermid | Reuters

MerckMonday, the company asked for authorization from Food and Drug Administration to use its antiviral experimental pill in an emergency to manage mild-to moderate Covid-19 symptoms in adults.

After the request by U.S. drugmaker, phase three clinical trial data released on October 1 showed the medication – known as molnupiravir – reduced the chances that patients newly diagnosed with Covid would be hospitalized by about 50%.

This drug prevents the virus from reproducing in the body. Merck’s molnupiravir, which is an intravenous drug from Gilead Sciences, can also be used by mouth. It would become the first drug to be approved in America by regulators. This could make a significant contribution to the fight against Covid.

“The pandemic’s extraordinary effect demands that we act with an unprecedented speed
“Urgency is the key, and our teams responded accordingly by submitting the application for molnupiravir at the FDA in 10 days after receiving the data,” Robert Davis, Merck CEO stated in a press release.

Americans could have the option to purchase the pill by mid-2017. Merck, who developed the drug in collaboration with Ridgeback Biotherapeutics said that the company is working actively with international regulatory agencies to submit emergency authorizations or applications “in coming months”.

The company has already agreed that it will supply approximately 1.7 millions courses of Molnupiravir to the U.S. if it is granted an FDA emergency use authorization. The New York Times reported that the five-day treatment will run at $700 for each patient. That’s a third more than what it costs to make monoclonal antibodies.

Although vaccinations are still the most effective form of protection, U.S. health officials hope that a Merck’s pill will prevent the spread of the virus and save lives.

Pills such as Merck’s can be considered a “sort of” medication.holy grail” for treatmentsLast week Dr. Mike Ryan was the executive director for the World Health Organization’s Health Emergencies Program.

Others drugmakers also work on antiviral medications. One created by PfizerAlbert Bourla, Pfizer’s CEO, stated that the Covid vaccine, developed in collaboration with BioNTech in the U.S., may be ready by the end-of this year.

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