Merck Submits Emergency Use Authorization Application to U.S. FDA for Oral Antiviral Molnupiravir in High-Risk Mild-to-Moderate COVID-19 Patients

Today, MSD and Ridgeback Biotherapeutics announced that MSD has submitted an application for Emergency Use Authorization (EUA) to the U.S. FDA for the investigational oral antiviral therapy molnupiravir, for the treatment of adult patients with mild-to-moderate COVID-19 who may be at risk of disease worsening or hospitalization. The two companies are also collaborating with regulatory agencies worldwide to submit applications for emergency use authorization or marketing approval. The press release noted that, if approved, molnupiravir would become the first oral antiviral therapy for COVID-19, providing a new weapon to help end the pandemic sooner.

This application is based on the interim analysis results from a Phase 3 clinical trial conducted in patients with mild to moderate COVID-19. The trial results showed that molnupiravir reduced the risk of hospitalization or death by approximately 50%. At 29 days post-treatment, 7.3% of patients in the molnupiravir group were hospitalized or died, compared to 14.1% in the placebo group (p=0.0012). No deaths occurred in the molnupiravir group, whereas 8 patients died in the control group.

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Regarding safety, the proportion of patients experiencing drug-related adverse events was similar between the two groups (12% and 11%). Fewer patients in the molnupiravir group discontinued treatment due to adverse events (1.3% and 3.4%).

Molnupiravir is an investigational oral potent ribonucleoside analogue that inhibits the replication of SARS-CoV-2. It was originally developed by scientists at Emory University. MSD and Ridgeback Biotherapeutics are currently conducting a Phase 3 clinical trial to evaluate its efficacy and safety in preventing the transmission of COVID-19 within households.

References:

[1] Merck and Ridgeback Announce Submission of Emergency Use Authorization Application to the U.S. FDA for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of Mild-to-Moderate COVID-19 in At Risk Adults. Retrieved October 11, 2021, from https://www.merck.com/news/merck-and-ridgeback-announce-submission-of-emergency-use-authorization-application-to-the-u-s-fda-for-molnupiravir-an-investigational-oral-antiviral-medicine-for-the-treatment-of-mild-to-moderate-c/

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