Merck asks FDA to approve emergency antiviral drugs


The Merck logo on the Merck campus in Rahway, New Jersey.

Brendan McDermid | Reuters

Merck said Monday it had asked the Food and Drug Administration to approve the emergency use of its experimental antiviral pill for the treatment of mild to moderate Covid-19 in adults.

The U.S. drugmaker’s inquiry came after Phase 3 clinical trial data released October 1 showed the drug – known as molnupiravir – reduced the likelihood of newly diagnosed patients being hospitalized with Covid by about 50% .

The drug works by stopping the virus from multiplying in the body. Unlike Gilead Sciences’ intravenous drug Remdesivir, Merck’s molnupiravir can be taken orally. If approved by U.S. regulators, it would be the first pill to treat Covid, a potentially groundbreaking advance in the fight against the virus, which kills an average of more than 1,600 Americans a day.

“The extraordinary effects of this pandemic require that we deal with unprecedented
Urgency, and that’s exactly what our teams did by filing this application for molnupiravir with the FDA within 10 days of receiving the data, “said Robert Davis, CEO of Merck, in a press release.

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

The company agreed earlier this year to ship approximately 1.7 million molnupiravir courses to the United States if it receives emergency approval or full approval from the FDA. According to The New York Times, five days of treatment with the drug costs the federal government about $ 700 per patient, one-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 like Merck’s will prevent disease progression in those who become infected and prevent trips to hospital.

Pills like Merck’s are considered a kind of “holy grail” for treatments, said Dr. Mike Ryan, Executive Director of the World Health Organization’s Emergency Health Program, at a news conference last week.

Other drug manufacturers are also working on antiviral pills. One of Pfizer, who developed BioNTech’s first approved Covid vaccine in the US, could be available by the end of this year, Pfizer CEO Albert Bourla told CNBC in April.



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