A 13-10 vote by the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) set the stage for recommending Emergency Use Authorization of the Merck and Ridgeback Biotherapeutics oral COVID-19 antiviral molnupiravir this week.
The narrow backing followed a day-long meeting of the advisory committee, which hashed out the risk-benefit analysis of the drug. The committee members ultimately ruled that the benefits outweighed the risks. If authorized in turn by the FDA, the drug could be utilized to treat mild to moderate COVID-19 cases among adults at high risk of worsening.
“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.,” Dr. Dean Y. Li, executive vice president and president of Merck Research Laboratories, said. “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.”
Molnupiravir was submitted for consideration following positive results from an interim analysis and study updates of the Phase 3 MOVe-OUT trial, which tested randomly on non-hospitalized adult patients with symptomatic, mild to moderate COVID-19 cases. These adults were at high risk for progressing to severe cases, including hospitalization or death.
“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,” Wendy Holman, CEO of Ridgeback Biotherapeutics, said. “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.”
At the time of the interim analysis, molnupiravir reduced hospitalization and death by approximately 50 percent. However, an additional analysis put the reduction at 30 percent. In all, nine deaths were reported in the placebo group, compared to one among those given molnupiravir.
Results appeared similar among various patient subgroups, including those infected with the Delta, Gamma, and Mu variants of COVID-19. No serious side effects emerged during the study.