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Merck Seeks EUA for COVID-19 Treatment
Molnupiravir reduced the risk of hospitalization or death by about 50%.
Merck has submitted an Emergency Use Authorization (EUA) application to the FDA for molnupiravir, an investigational oral antiviral medicine, for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.
The submission is based on positive results from a planned interim analysis from the phase 3 MOVe-OUT clinical trial. At the interim analysis, molnupiravir reduced the risk of hospitalization or death by about 50%. The incidence of drug-related adverse events was 12% in the molnupiravir group versus 11% in the placebo cohort, and fewer subjects in the molnupiravir group discontinued therapy due to an adverse event compared with the placebo group.
Related:Data Show Merck’s Oral Antiviral Cuts Risk of Death from COVID-19 in Half
Molnupiravir was invented at Drug Innovations at Emory, a not-for-profit biotechnology company wholly owned by Emory University. Molnupiravir is being developed by Merck in collaboration with Ridgeback Biotherapeutics.
The companies are actively working with regulatory agencies worldwide to submit applications for emergency use or marketing authorization in the coming months.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
