Merck & Co. Files for Emergency Use Authorization for Oral COVID-19 Drug
Merck & Co. has submitted an emergency use authorization (EUA) application to the US Food and Drug Administration (FDA) for molnupiravir, an investigational oral antiviral agent for treating mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.
Molnupiravir is being developed by Merck & Co. in collaboration with Ridgeback Biotherapeutics, a Miami, Florida-based bio/pharmaceutical company. The companies formed a collaboration and licensing agreement in July 2020 to develop the drug under which Merck acquired exclusive worldwide rights to develop molnupiravir and related molecules in collaboration with Ridgeback. Molnupiravir was invented at Drug Innovations at Emory LLC, a not-for-profit biotechnology company wholly owned by Emory University.
The submission is based on positive results from a planned interim analysis from a Phase III trial, which evaluated molnupiravir in non-hospitalized adult patients with mild-to-moderate COVID-19 who were at risk for progressing to severe COVID-19 and/or hospitalization. At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%.
In anticipation of the results from the Phase III trial 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 more courses expected to be produced in 2022.
Earlier this year (2021), Merck entered into a procurement agreement with the US government under which the company will supply approximately 1.7 million courses of molnupiravir to the US government, upon EUA or approval from the 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.
To facilitate global access to the drug if it is authorized or approved, Merck says it plans to implement a tiered pricing approach based on World Bank country income criteria to reflect countries’ relative ability to finance their health response to the pandemic. In addition, Merck previously announced that the company has entered into non-exclusive voluntary licensing agreements for molnupiravir with established Indian generic-drug manufacturers to accelerate availability of molnupiravir in more than 100 low- and middle-income countries following approvals or emergency authorization by local regulatory agencies.
The companies say they are actively working with regulatory agencies globally to submit applications for emergency use or marketing authorization in the coming months (as reported on October 11, 2021).
Molnupiravir is also being evaluated for post-exposure prophylaxis in a Phase III trial, which is evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID-19 within households.
The FDA’s Antimicrobial Drugs Advisory Committee will meet on November 30, 2021 to discuss the available data supporting the use of molnupiravir to treat mild-to-moderate COVID-19 in adults who have tested positive for COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death.