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www.fdanews.com/articles/204817-merck-and-ridgeback-seek-eua-for-covid-19-oral-antiviral

Merck and Ridgeback Seek EUA for COVID-19 Oral Antiviral

October 13, 2021

Merck and Ridgeback Biotherapeutics have become the first companies to file an application seeking Emergency Use Authorization (EUA) for an oral antiviral that treats COVID-19 — which could transform treatment of infections with the deadly virus.

The companies said a late-stage trial showed the investigational antiviral molnupiravir, which they co-developed, cut the risk of hospitalization or death by 50 percent in COVID-19 patients with mild or moderate infections.

The results came from an interim report of the company’s phase 3 study. An independent data monitoring committee recommended that Merck stop the study early due to positive results, and the FDA agreed, the companies said.

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