In December 2021, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.In October 2021, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) started a rolling review of molnupiravir.In November 2021, molnupiravir was approved in the U.K. by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of established infections of COVID-19. The MHRA issued a conditional marketing authorization applicable in the U.K., and an emergency use authorization for Northern Ireland.In November 2021, the Bangladesh Directorate General of Drug Administration (DGDA) authorized emergency use of molnupiravir.In January 2022, molnupiravir was approved for medical use in Israel. Names
Molnupiravir is the international nonproprietary name (INN).Generic versions are available under the brand names Molulife (Mankind) and Molena (Emcure). Public health concerns
At a November 2021 AMDAC meeting, multiple advisors raised the concern that molnupiravir could accelerate the emergence of variants of concern. Other scientists raised similar concerns both before and after the meeting. Research
COVID-19 clinical trial
In October 2021, preliminary results from a clinical trial (MOVe-OUT) indicated that treatment with molnupiravir may reduce the risk of hospitalization and death from COVID-19.
Society and culture
Economics
In September 2021, Merck signed a voluntary licensing agreement with the Medicines Patent Pool (MPP) that allows MPP to sublicense molnupiravir and supply the COVID-19 oral medication to 105 low- and middle-income countries. The cost of the U.S. governments initial purchase was about $712 per course of treatment; treatment with generics in developing countries can cost as little as $20. Legal status
On 11 October 2021, Merck submitted an EUA application to the FDA, and on 30 November 2021, the FDAs Antimicrobial Drugs Advisory Committee (AMDAC) at the Center for Drug Evaluation and Research met to discuss the application. The committee narrowly voted, 13 for and 10 opposed, to recommend authorization for adults with mild to moderate illness who are at high risk of developing severe COVID-19. Concerns were expressed over the drugs low effectiveness in preventing death, which in the final trial was only 30%, as well as the increased mutation rate the drug causes, which could theoretically worsen the pandemic by driving the evolution of more dangerous variants.