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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorization for Merck and Ridgeback Therapeutics’ molnupiravir (to be trademarked LAGEVRIO in the UK). Results from an interim analysis from the Phase III MOVe-OUT clinical trial showed that the oral treatment could halve the risk of hospitalization or death for adults with a positive SARS-CoV-2 diagnostic test and mild to moderate COVID symptoms and who had at least one risk factor have at least one risk factor for developing severe illness.
The approval is ”a major achievement in Merck’s singular legacy of bringing forward breakthrough medicines and vaccines to address the world’s greatest health challenges,“ said Robert M. Davis, the company’s chief executive officer and president.
Wendy Holman, chief executive officer of Ridgeback Biotherapeutics, commented: ”It is also gratifying to see the first global authorization occur in the UK, the very place where we administered molnupiravir to the first brave human volunteer.”