If the FDA authorizes molnupiravir, it would be the first oral anti-viral to treat COVID-19 that patients can take at home.
The FDA’s Antimicrobial Drugs Advisory Committee has voted 13 to 10 to support emergency authorization of Merck/Ridgeback’s oral anti-viral to treat mild-to-moderate COVID-19 in adults.
The narrow vote comes just after Merck announced analysis of updated data that indicated molnupiravir may not be as effective as first thought. Merck now says molnupiravir reduces the risk of hospitalization or death from COVID-19 by 30% after all data have been analyzed. Previously, an interim analysis showed a 50% reduction in hospitalization or death.
The updated analysis of all enrolled patients in the study of molnupiravir showed that the antiviral to treat COVID-19 reduced the risk of hospitalization or death from 9.7% in the placebo group to 6.8% in the molnupiravir group, for a relative risk reduction of 30%. In October 2021, however, developers Merck and Ridgeback provided an interim analysis that found 7.3% of patients who received molnupiravir were either hospitalized or died through day 29 following randomization, compared with 14.1% of placebo-treated patients.
“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, chief executive officer of Ridgeback Biotherapeutics, said in a statement.
Some committee members raised concerns about the safety of molnupiravir, especially in children and women who are pregnant because of the potential for adverse events and birth defects.
Molnupiravir is also being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a global, phase 3 study.
In anticipation of regulatory authorization, Merck has been producing molnupiravir at risk and expects to produce 10 million courses of treatment by the end of 2021, with at least 20 million courses to be produced in 2022. Merck entered into a procurement agreement with the U.S. government to supply about 3.1 million courses.