The agency found Lagevrio (molnupiravir) to be safe and effective at reducing the risk of death and hospitalization for those with mild to moderate COVID-19 infections.
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) announced on Nov. 4, 2021 that it has determined that the antiviral drug Lagevrio (molnupiravir) is safe and effective at reducing the risk of death and hospitalization for those with mild to moderate COVID-19 infections. MHRA made the determination after a review of the drug’s safety, quality, and effectiveness by the UK’s Commission on Human Medicines.
Lagevrio, developed by Ridgeback Biotherapeutics and Merck Sharp & Dohme (MSD), interferes with replication of SARS-CoV-2, according to MHRA, which keeps virus levels low in the body. It is most effective when taken early in the infection stages. It has been authorized for use in those with mild to moderate COVID-19 who also have at least one risk factor.
“Lagevrio is another therapeutic to add to our armoury against COVID-19. It is also the world’s first approved antiviral for this disease that can be taken by mouth rather than administered intravenously. This is important, because it means it can be administered outside of a hospital setting, before COVID-19 has progressed to a severe stage. With no compromises on quality, safety, and effectiveness, the public can trust that the MHRA has conducted a robust and thorough assessment of the data,” said Dr June Raine, MHRA chief executive, in a press release.
Source: MHRA
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July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
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