FDA Advisory Committee Votes for Oral Antiviral Molnupiravir to Treat COVID-19 in High Risk Adults

Merck and Ridgeback Biotherapeutics provided the following statement at the conclusion of the FDA Antimicrobial Drugs Advisory Committee (AMDAC) regarding the Emergency Use Authorization (EUA) application for molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, for the treatment of mild to moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19 and/or hospitalization. The Advisory Committee voted 13-10 that the known and potential benefits of molnupiravir outweigh its known and potential risks for the treatment of mild to moderate COVID-19 in high risk adult patients who are within five days of symptom onset. The FDA is not bound by the committee’s guidance but takes its advice into consideration.

“The positive outcome of today’s FDA Advisory Committee meeting, following a comprehensive review of molnupiravir, including the compelling data from the MOVe-OUT study demonstrating a significant reduction in hospitalizations and deaths, is a critical step toward bringing this promising oral medicine for COVID-19 to appropriate patients in the U.S. With the continued spread of the virus and the emergence of variants, additional treatments for COVID-19 are urgently needed. That is why we are moving with speed and rigor to pursue authorizations and to accelerate broad global access to this investigational medicine,” said Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories. “We are grateful to the members of the Advisory Committee who reviewed our application, as well as to the patients and investigators who participated in our clinical trials, and we will continue to work with the FDA as the agency completes its review.”

“We are one step closer to being able to add molnupiravir to the tools that we have – in addition to vaccines – that can be available and accessible to help fight COVID-19. Importantly, our data show activity against the most prevalent variants today, and molnupiravir was studied as a monotherapy with no drug-drug interactions observed to date. We will continue to work with urgency to bring this investigational medicine forward to appropriate patients,” said Wendy Holman, chief executive officer, Ridgeback Biotherapeutics.

Under an EUA, to help strengthen the nation’s protection against public health threats, such as SARS-CoV-2, the FDA may authorize unapproved medical products or unapproved uses of approved medical products in a public health emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain criteria are met, including when there are no adequate, approved, and available alternatives. The AMDAC provides the FDA with independent, expert advice and recommendations for consideration in making final decisions, including decisions related to authorization.