Merck asks FDA for EUA for COVID-19 pill that halves hospitalizations and death

On Monday, Merck and partner Ridgeback Biotherapeutics LP asked the Food and Drug Administration (FDA) to give its COVID-19 pill emergency use authorization (EUA). They filed an application for their pill molnupiravir as the next step forward after receiving promising results in trials from a late-stage study. According to the company, its antiviral drug decreased hospitalizations or death due to COVID-19 by 50 percent in high risk individuals who had mild or moderate infections, as per data obtained in phase three clinical trials.

If the FDA authorizes emergency use approval, molnupiravir could become the first oral pill to be used to treat COVID-19. It reportedly stops the virus from replicating itself and this could stop its spread throughout the human body. It was originally formulated to treat influenza. It can be taken at home and would not require patients to go to hospitals to get treated.

Emory University had developed the drug at Drug Innovation Ventures at Emory (DRIVE). The drug innovation company, based in Atlanta, had licensed its use to Ridgeback Biotherapeutics, who in turn partnered with the Summit, New Jersey giant pharmaceutical Merck.

Merck has released the results of the clinical trials. The results have not been peer reviewed. Side effects were mild but were not mentioned by Merck.

According to the Daily Mail, trials were also conducted with generic versions in India but were stopped for moderate cases as the medication did not show “significant efficacy.” However, the pills were successful when used for mild cases. Incidentally different countries classify mild and moderate cases according to their own regulations.

Merck also said that it was working with other regulatory agencies around the world. It has said that the U.S. will be supplied with roughly 1.7 million courses, if the FDA authorizes EUA or full approval. The New York Times reported that a five-day course of molnupiravir would cost approximately $700 per person. Monoclonal antibodies, the current treatment, costs the federal government three times as much as that of molnupiravir.

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