Merck to seek emergency use authorization for Molnupiravir, oral antiviral medicine for COVID-19

Merck to seek emergency use authorization for Molnupiravir, oral antiviral medicine for COVID-19

October 5, 2021 Off By Dino Mustafić

The drug maker Merck said it plans to seek emergency use authorization in the U.S. as soon as possible and to submit applications to regulatory agencies worldwide for Molnupiravir, which could be the first oral antiviral medicine for COVID-19.

Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that an investigational oral antiviral medicine molnupiravir, significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized adult patients with mild-to-moderate COVID-19.

To remind, Merck in January said it dropped development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591, and turned to focus its SARS-CoV-2/COVID-19 research strategy and production capabilities on advancing two therapeutic candidates, molnupiravir MK-4482, and MK-7110.

Merck said in a press release that, at the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo, the drug maker said. At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA), recruitment into the study is being stopped early due to these positive results.

Robert M. Davis, chief executive officer and president of Merck was referred to as saying in the press release that 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.  Davis said that with the compelling results, there is optimism at Merck that molnupiravir can become an important medicine as part of the global effort to fight the pandemic. “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, chief executive officer of Ridgeback Biotherapeutics said 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. 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,” Homaln said.

About Merck’s Efforts to Enable Access to Molnupiravir, if it is Granted EUA or Approval

Merck also said in the press release that, in anticipation of the results from MOVe-OUT, it has been producing molnupiravir at risk. The drug maker said it expects to produce 10 million courses of treatment by the end of 2021, with more doses expected to be produced in 2022. Read more at this link, and also here.

Merck noted that it has entered earlier this year 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 said it has entered into supply and purchase agreements for molnupiravir with other governments worldwide, pending regulatory authorization, and is currently in discussions with other governments.

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