In its latest meeting in late January 2026, the EMA’s Committee for Medicinal Products for Human Use (CHMP) released pivotal recommendations, clearing the path for several new therapies while intensifying scrutiny on products with data integrity concerns.
Key Licensing and Label Expansion Highlights:
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Milestone for MASH Treatment: Novo Nordisk’s semaglutide received a positive opinion for conditional marketing authorization to treat metabolic dysfunction-associated steatohepatitis (MASH). In Europe, this medication will be marketed under the new brand name Kayshild, distinguishing it from its U.S. counterpart, Wegovy.
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Mounjaro’s Regulatory Status: Regarding Eli Lilly’s bid for chronic heart failure in obese patients, the CHMP opted against a separate indication. Instead, it agreed to include relevant trial data on the product label to provide clinicians with updated evidence, noting uncertainty over whether the benefits were independent of weight loss.
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Breakthroughs in Rare Diseases and Vaccines: UCB’s Kygevvi earned a positive opinion under “exceptional circumstances” for the rare genetic condition TK2d. Sanofi also secured wins for its flu vaccine Supemtek and the drug Rezurock (for chronic GVHD) following a commitment to conduct post-approval confirmatory studies.
Data Integrity Scrutiny: A significant regulatory development involves the re-evaluation of Amgen’s Tavneos, a treatment for rare inflammatory blood vessel conditions. The European Commission requested a formal review following emerging concerns regarding the handling of clinical trial data prior to the drug’s initial authorization. The EMA will now assess the benefit-risk profile to determine whether the marketing authorization should be maintained, amended, suspended, or withdrawn.