Oct. 11, 2021 – Merck Requests Emergency Use Authorization for Molnupiravir:
On October 11, 2021, Merck and Ridgeback Therapeutics announced their Emergency Use Authorization application to the U.S. Food and Drug Administration (FDA) for molnupiravir, which is an investigational oral treatment for mild-to-moderate COVID-19 in adults at risk of hospitalization. If approved, molnupiravir will be the first oral medication available to treat COVID-19. In anticipation of receiving regulatory authorization for molnupiravir, Merck has already begun manufacturing the medication and expects to produce 10 million courses of treatment by the end of 2021. Additionally, Merck has entered into an agreement with the U.S. government to supply 1.7 million courses of treatment of molnupiravir following Emergency Use Authorization or full approval from the FDA. Merck has entered into similar agreements with other governments worldwide pending regulatory authorization. Additionally, Merck has entered into non-exclusive voluntary licensing agreements with generic pharmaceutical manufacturers to accelerate the availability of molnupiravir in over 100 low- and middle-income countries following regulatory authorization.
More information about molnupiravir and the clinical study that supports Merck’s application for Emergency Use Authorization can be found here.
On December 23, 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for molnupiravir, which is a treatment for COVID-19 manufactured by Merck. The EUA for molnupiravir authorizes its use for the treatment of patients with mild-to-moderate COVID-19 who are at high risk of severe COVID-19 and who are unable to utilize alternate treatment options.
On December 22, 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Paxlovid, which is an oral antiviral treatment for COVID-19 manufactured by Pfizer. The EUA for Paxlovid authorizes its use for the treatment of adults and children over the age of 12 with mild-to-moderate COVID-19 who are at high-risk of severe COVID-19.
On October 1, 2021, Merck announced the results of the planned interim analysis of the MOVe-OUT Phase 3 clinical trial, which is investigating the safety and efficacy of an oral antiviral treatment for non-hospitalized patients with mild-to-moderate COVID-19.
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