Merck and Ridgeback Biotherapeutics have submitted a request to the Food and Drug Administration (FDA) for Emergency Use Authorization for molnupiravir, an investigational oral antiviral 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 results from a planned interim analysis from the phase 3 MOVe-OUT trial (ClinicalTrials.gov Identifier: NCT04575597), which evaluated the efficacy and safety of molnupiravir in 775 nonhospitalized adults with symptom onset within 5 days of randomization. Patients were also required to have at least 1 risk factor associated with poor disease outcomes.
Findings showed that treatment with molnupiravir reduced the risk of hospitalization or death by approximately 50%. Following randomization, 7.3% (n=28/385) of patients treated with molnupiravir were either hospitalized or died through day 29 compared with 14.1% (n=53/377) of patients treated with placebo (P =.0012). Additionally, there were no deaths reported in the molnupiravir arm through day 29, compared with 8 deaths in the placebo arm.
Adverse events were found to be comparable between the groups. Fewer patients discontinued treatment due to adverse events in the molnupiravir arm vs the placebo arm (1.3% vs 3.4%).
“The submission to the FDA is a critical step towards making molnupiravir available to people who may benefit from an oral antiviral medicine that can be taken at home shortly after diagnosis with COVID-19,” said Wendy Holman, CEO of Ridgeback Biotherapeutics. “We are pleased to partner with Merck and regulatory authorities to help provide molnupiravir to the people who need it here in the US and around the world.”
Merck and Ridgeback announce submission of Emergency Use Authorization Application to the US FDA for molnupiravir, an investigational oral antiviral medicine, for the treatment of mild-to-moderate COVID-19 in at risk adults. News release. Merck and Ridgeback Biotherapeutics. Accessed October 12, 2021. https://www.businesswire.com/news/home/20211011005110/en/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.