KENILWORTH, N.J. & MIAMI–(October 11, 2021)– Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that Merck has submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (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 companies are actively working with regulatory agencies worldwide to submit applications for emergency use or marketing authorization in the coming months.
The submission is based on positive results from a planned interim analysis from the Phase 3 MOVe-OUT 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. At the interim analysis, 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 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo.
The incidence of any adverse event was comparable in the molnupiravir and placebo groups (35% and 40%, respectively). The incidence of drug-related adverse events was also comparable (12% and 11%, respectively), and fewer subjects in the molnupiravir group discontinued therapy due to an adverse event compared to the placebo group (1.3% and 3.4%, respectively).
Merck said in a press release that “The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” said Robert M. Davis, chief executive officer and president, Merck.
FDA drug could approval the antiviral drug in the coming weeks. The drug targets the spike protein, molnupiravir and targets a part of the virus that helps it reproduce. The healthcare professional and patients have been waiting for an at home drug which could be administered at home–preventing a mild case of COVID-19 from worsening and requiring hospitalization.
Source: Merck wrote the original article.