Generics
Merck and Ridgeback files EUA with U.S. FDA for molnupiravir for treatment of mild-to-moderate COVID-19 in at risk adults
12 October 2021 -

Ridgeback Biotherapeutics said on Monday that Merck (NYSE:MRK) has submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for the investigational oral antiviral medicine molnupiravir for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.

According to the companies, Molnupiravir (MK-4482/EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19.

Under a planned interim analysis from the company's Phase 3 MOVe-OUT clinical trial, molnupiravir reportedly reduced the risk of hospitalization or death by 50%. Through Day 29, no deaths were reported in patients who received molnupiravir.

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 10m courses of treatment by the end of 2021, with more courses expected in 2022.

Additionally, Merck will supply 1.7m courses of molnupiravir to the U.S. Government upon EUA or approval from the U.S. FDA, launched supply and advance purchase agreements with other governments worldwide, announced non-exclusive voluntary licensing agreements with Indian generic manufacturers to accelerate its availability 100 low- and middle-income countries (LMICs), respectively.

If molnupiravir is authorized or approved, Merck 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.

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