The rolling review by the European Medicines Agency of the antiviral pill which, according to data from the pharmaceutical company Merck, reduces the risk of hospitalization of mild or moderate Covid cases by up to 50%. Pharmaceutical company MSD – known as Merck in the United States and Canada – and Ridgeback Biotherapeutics have announced that the EMA has initiated an ongoing review for Molnupiravir, the investigational oral antiviral drug in adults. If marketing authorization is granted by the European Commission, the companies say, Molnupiravir could be the first antiviral pill to treat Sars Cov 2 disease in the European Union.
The company plans to work with EMA’s Committee for Medicinal Products for Human Use (CHMP) to complete the review process to facilitate the initiation of the formal review of the marketing authorization application. As previously announced, an emergency use authorization application has been submitted to Food and Drug Administration (Fda) US and is actively working for submit applications to other regulatory agencies around the world. The submission of the application is based on the positive results of an interim analysis of the MOVe-OUT Phase 3 clinical trial, which evaluated Molnupiravir in outpatient adult patients with mild to moderate Covid who were at increased risk of progression to severe disease. and / or hospitalization. The analysis showed that the antiviral administered twice a day reduced the risk of hospitalization or death by about 50%.
“The global scientific community has made extraordinary progress in developing several critical vaccines and treatments, but we still need an oral antiviral drug that can be taken at home – he said.o Wendy Holman, CEO Ridgeback Biotherapeutics – We believe molnupiravir can help meet that need. ” “MSD manufactured molnupiravir at its own risk and plans to produce 10 million treatment cycles by the end of 2021, and more in 2022. As part of the commitment to widespread global access, MSD previously announced that the company has entered into non-exclusive voluntary licensing agreements for molnupiravir with Indian generic drug manufacturers to accelerate the availability of molnupiravir in more than 100 low- and middle-income countries following emergency approvals or clearances from local regulatory agencies ”.
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