The filing is for the first oral antiviral therapy, and is based off its phase 3 trial.
Merck announced today the company has submitted an Emergency Use Authorization (EUA) application to Food and Drug Administration (FDA) for its therapy, molnupiravir (MK-4482/EIDD-2801), for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.
Molnupiravir is an investigational therapy that would be the first of its kind as an oral antiviral medicine. The filing comes less than 2 weeks after reporting its data.
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,” Robert M. Davis, chief executive officer and president, Merck, said.
The filing is based on its phase 3 MOVe-OUT trial which was an international randomized, controlled, double-blinded assessment of molnupiravir versus placebo in non-hospitalized adults with mild to moderate COVID-19.
Investigators planned to evaluate interim data from 775 MOVe-OUT participants who were enrolled prior to August 5 of this year.
The interim analysis showed molnupiravir reduced patient risk of COVID-19 hospitalization or death by approximately 50%. Just 28 (7.3%) of patients to receive molnupiravir experienced either outcome, versus 53 (14.1%) patients administered placebo (P = .0012). No patients to receive molnupiravir had died through 29 days post-randomization, versus 8 patients to receive placebo.
The therapy is an a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. The therapy has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission. Additionally, pre-clinical and clinical data have shown molnupiravir to be active against the most common SARS-CoV-2 variants.
Molnupiravir was invented at Drug Innovations at Emory (DRIVE) and developed by Merck and Ridgeback Biotherapeutics. Merck and Ridgeback will be pursuing an indication similar to antivirals granted EUAs in the past: for the treatment and prevention of severe outcomes associated with COVID-19. On the basis of guidance from an independent data monitoring committee and the FDA, the companies have stopped recruitment for the phase 3 study due to the positive interim results, and are planning to produce 10 million treatment courses by the end of the year.
No timeline has been established for FDA review.