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October 15, 2021

Health Law Weekly

Merck Submits EUA Application to FDA for New COVID-19 Treatment

  • October 15, 2021

Pharmaceutical giant Merck has submitted an Emergency Use Authorization (EUA) application to the Food and Drug Administration (FDA) for molnupiravir, an investigational oral antiviral drug, the company announced October 11.

The request is based on positive results from a Phase 3 clinical trial, which evaluated molnupiravir in non-hospitalized adult patients with mild-to-moderate COVID-19 who were at risk for progressing to severe COVID-19 and/or hospitalization, according to a press release.

During the trial, molnupiravir reduced the risk of hospitalization or death by approximately 50%--7.3% of patients who received molnupiravir were either hospitalized or died through Day 29, compared with 14.1% of placebo-treated patients, the release said.

Merck indicated that it would be ready to distribute the drug once approved. The company earlier this year entered into a procurement agreement with the U.S. government to supply approximately 1.7 million courses of molnupiravir upon EUA or approval from the FDA.

An FDA advisory panel will discuss the EUA request at a meeting scheduled for November 30, the agency said in a statement

"We believe that, in this instance, a public discussion of these data with the agency’s advisory committee will help ensure clear understanding of the scientific data and information that the FDA is evaluating to make a decision about whether to authorize this treatment for emergency use,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, in the October 14 statement. 

 

 

ARTICLE TAGS
  • Coronavirus Pandemic
  • Life Sciences