Merck seeking FDA emergency use authorization for oral COVID-19 treatment

Merck and Ridgeback Biotherapeutics have submitted an emergency-use application to the FDA for use of molupiravir, an oral experimental antiviral treatment for mild-to-moderate COVID-19, in adults who are at risk of the COVID-19 virus progressing to severe disease or hospitalization. 

If approved, this would be the first such drug. The treatment, a ribonucleoside analogue, works by inhibiting replication of the SARS-CoV-2 virus.

The companies made this move based on the positive results from an interim data analysis in the phase 3 MOVe-OUT study.

The analysis showed that in this high-risk group of patients the risk of hospitalization or death decreased by about 50%.

According to the companies, the results were based on results from more than 700 patients who received molnupiravir or placebo.

Robert M. Davis

According to Robert M. Davis, CEO and president of Merck, more tools and treatments are urgently needed to fight the COVID-19 pandemic, which has become a leading cause of death and continues to profoundly affect patients, families, and societies and strain health care systems all around the world.

“With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic and will add to Merck’s unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most,” he said in a statement. “Consistent with Merck’s unwavering commitment to save and improve lives, we will continue to work with regulatory agencies on our applications and do everything we can to bring molnupiravir to patients as quickly as possible.”

Wendy Holman, CEO of Ridgeback Biotherapeutics, agreed, noting that with the virus continuing to circulate widely, and because therapeutic options currently available are infused and/or require access to a healthcare facility, antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed.

“We are very encouraged by the results from the interim analysis and hope molnupiravir, if authorized for use, can make a profound impact in controlling the pandemic,” she said in a statement. “Our partnership with Merck is critical to ensuring rapid global access if this medicine is approved, and we appreciate the collaborative effort to reach this important stage of development.”

In addition to the MOVe-OUT study, molnupiravir is also being evaluated in the MOVe-AHEAD study, that is evaluating prophylaxis after exposure to COVID-19 in households.

In anticipation of the results from MOVe-OUT, Merck has been producing molnupiravir at risk. Merck expects to produce 10 million courses of treatment by the end of 2021, with more doses expected to be produced in 2022.

Earlier this year, Merck entered into a procurement agreement with the U.S. Government under which Merck will supply approximately 1.7 million courses of molnupiravir to the U.S. government, upon EUA or approval from the U.S. FDA.

Additionally, Merck has entered into supply and purchase agreements for molnupiravir with other governments worldwide, pending regulatory authorization, and is currently in discussions with other governments.