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# Merck Seeking EUA for Covid-19 Oral Drug
- URL: https://www.fdaweb.com/merck-seeking-eua-for-covid-19-oral-drug/
- Published: 2021-10-01T12:00:00.000Z
- Updated: 2026-09-14T17:17:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150274

Merck plans to submit soon an application seeking emergency use authorization (EUA) for molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine that new data show significantly reduced the risk of hospitalization or death in Covid-19 patients. Merck and developmental partner Ridgeback Biotherapeutics just announced data from a planned interim analysis of the Phase 3 MOVe-OUT trial that show molnupiravir reduced the risk of hospitalization or death by about 50% — 7.3% of patients who received molnupiravir were either hospitalized or died through day 29 following randomization compared with 14.1% of placebo-treated patients. Also, the companies say, no deaths were reported in patients who received molnupiravir, compared with eight deaths in patients who received placebo. The companies add that an independent data monitoring committee, in consultation with FDA, recommended an early stop to recruitment in the study.

Earlier this year, Merck [entered](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.merck.com%2Fnews%2Fmerck-announces-supply-agreement-with-u-s-government-for-molnupiravir-an-investigational-oral-antiviral-candidate-for-treatment-of-mild-to-moderate-covid-19%2F&esheet=52502008&newsitemid=20211001005189&lan=en-US&anchor=entered&index=1&md5=f1eb49a20aceb153a2c5e31cfdfa3f71&ref=fdaweb.com) into an agreement with the U.S. government where the company will supply about 1.7 million courses of molnupiravir upon obtaining the EUA. Additionally, Merck has entered into supply and purchase agreements for molnupiravir with other governments worldwide. “In anticipation of the results from MOVe-OUT, Merck has been producing molnupiravir at risk,” the companies say. “Merck expects to produce 10 million courses of treatment by the end of 2021, with more doses expected to be produced in 2022.”