Merck asks FDA to authorize antiviral Covid pill for emergency use

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  • Merck said it has asked the FDA to authorize emergency use of its experimental antiviral pill to treat mild to moderate COVID-19 in adults.
  • Data from a Phase III clinical trial showed the drug – known as molnupiravir – reduces the likelihood that patients newly diagnosed with Covid will be hospitalized by about 50%.
  • The experimental drug could be available to Americans by the end of this year.

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Merck said on Monday 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.

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The US drugmaker’s request came after data from a phase III clinical trial released on October 1 showed the drug – known as molnupiravir – reduces the likelihood that new cases of covid Up to 50% of patients will be hospitalized.

The drug works by stopping the replication of the virus inside the body. Unlike Gilead Sciences’ intravenous drug remdesivir, Merck’s molanupiravir can be taken by mouth. If approved by US 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.

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“The extraordinary impact of this pandemic demands that we move forward in an unprecedented way”
urgency, and that’s what our teams did by submitting this application for molnupirvir to the FDA within 10 days of receiving the data,” Merck CEO Robert Davis said in a press release.

The pill could be available to Americans by the end of this year. Merck, which developed the drug with Ridgeback Biotherapeutics, said it is actively working with regulatory agencies around the world to submit applications for emergency use or authorization “in the coming months”.

The company agreed earlier this year to supply approximately 1.7 million courses of mollupiravir to the US if it receives emergency use authorization or full approval from the FDA. According to The New York Times, a five-day course of the drug would cost the federal government about $700 per patient, which is a third of the current cost of monoclonal antibodies.

While vaccination is the best way to protect against the virus, US officials and health experts are hopeful that a pill like Merck will prevent further progression of the disease in people who become infected and prevent hospital visits.

Dr. Mike Ryan, executive director of the World Health Organization’s health emergencies program, said in a press conference last week, pills like Merck are considered the “holy grail” for treatment.

Other drugmakers are also working on antiviral pills. One made by Pfizer, which together with BioNTech developed the first authorized COVID vaccine in the US, could be available by the end of this year, Albert Boerla, Pfizer CEO, told CNBC in April.

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