Merck and Ridgeback Report Full Phase 3 Analysis for Oral Antiviral COVID Pill; Efficacy Plunges from Interim Analysis

Merck and Ridgeback Report Full Phase 3 Analysis for Oral Antiviral COVID Pill; Efficacy Plunges from Interim Analysis

Merck and Ridgeback Biotherapeutics provided an update on the MOVe-OUT study of molnupiravir (MK-4482, EIDD-2801), an oral antiviral medicine for COVID-19. The full data show molnupiravir reduced the risk of hospitalization or death for patients with mild or moderate COVID-19 by about 30%, based on a study of more than 1,400 adults. Last month, an interim analysis showed about 50% efficacy, based on data from 775 patients. 

The final analysis is from all enrolled patients (n=1,433). In this study population, molnupiravir reduced the risk of hospitalization or death from 9.7% in the placebo group (68/699) to 6.8% (48/709) in the molnupiravir group, for an absolute risk reduction of 3.0% and a relative risk reduction of 30%. Nine deaths were reported in the placebo group, and one in the molnupiravir group. In October, the companies submitted an Emergency Use Authorization application to the FDA based on interim data from the MOVe-OUT study. At the planned interim analysis, molnupiravir significantly reduced the risk of hospitalization or death from 14.1% (53/377) in the placebo group to 7.3% (28/385) in the molnupiravir, for a relative risk reduction of 48%. 

The MOVe-OUT tria...

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