Merck (MRK) And Ridgeback Announce Initiation of a Rolling Review by EU Agency for Molnupiravir,
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the European Medicines Agency (EMA) has initiated a rolling review for molnupiravir, an investigational oral antiviral medicine, for the treatment of COVID-19 in adults. Merck plans to work with the EMA’s Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process to facilitate initiating the formal review of the Marketing Authorization Application. As previously announced, Merck has submitted an application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA), and is actively working to submit applications to other regulatory agencies worldwide.
“This application to the EMA is another step in our efforts to bring molnupiravir forward to patients globally,” said Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories. “We believe that molnupiravir will be an important addition to the range of public health tools to fight COVID-19 – including the vaccines developed by the research-based pharmaceutical industry, which remain essential and are the first-line of defense against this pandemic.”
The submission is based on positive results from a planned interim analysis from the Phase 3 MOVe-OUT clinical trial, which evaluated molnupiravir in non-hospitalized adult patients with mild-to-moderate COVID-19 who were at increased risk for progressing to severe COVID-19 and/or hospitalization. At the interim analysis, molnupiravir 800 mg twice-daily reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were hospitalized through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377) that were either hospitalized or died; 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 incidence of any adverse event was comparable in the molnupiravir and placebo groups (35% and 40%, respectively). The incidence of drug-related adverse events was also comparable (12% and 11%, respectively), and fewer patients in the molnupiravir group discontinued therapy due to an adverse event compared to the placebo group (1.3% and 3.4%, respectively).
“In the nearly two years since COVID-19 emerged, the global scientific community has made extraordinary strides in developing several critical vaccines and treatments, but we still have a need for an oral antiviral medicine that can be taken at home,” said Wendy Holman, chief executive officer, Ridgeback Biotherapeutics. “We believe that molnupiravir, with the exciting finding of reduction in hospitalization and death in the MOVe-OUT study, may help fill that need and look forward to working with the EMA on its review.”
About Merck’s Efforts to Enable Global Access to Molnupiravir, if it is Granted Authorization or Approval
In anticipation of the results from MOVe-OUT and the potential for regulatory authorization or approval, Merck has been producing molnupiravir at risk and expects to produce 10 million courses of treatment by the end of 2021, with even more courses expected to be produced in 2022.
On October 11, Merck and Ridgeback announced that Merck had submitted an application for EUA to the U.S. FDA for molnupiravir for the treatment of at-risk adults with mild-to-moderate COVID-19. Additional submissions to global regulatory agencies are underway.
Earlier this year, Merck entered into a procurement agreement with the U.S. Government under which the company will supply approximately 1.7 million courses of molnupiravir to the U.S. Government following EUA or approval from the U.S. FDA. Additionally, Merck has entered into supply and advance purchase agreements for molnupiravir with other governments worldwide, pending regulatory authorization, and is currently in discussions with additional governments.
Merck is committed to providing timely access to molnupiravir globally, if it is authorized or approved, and plans to implement a tiered pricing approach based on World Bank country income criteria that reflect countries’ relative ability to finance their health response to the pandemic.
As part of its commitment to widespread global access, Merck previously announced that the company has entered into non-exclusive voluntary licensing agreements for molnupiravir with established Indian generic manufacturers to accelerate availability of molnupiravir in more than 100 low- and middle-income countries (LMICs) following approvals or emergency authorization by local regulatory agencies. Merck continues to discuss additional measures and collaborations to accelerate broad, global access to molnupiravir.