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www.fdanews.com/articles/212938-ema-expands-review-of-glp-1-agonists-and-suicide-while-weight-loss-drug-market-looks-to-expand

EMA Expands Review of GLP-1 Agonists and Suicide, While Weight Loss Drug Market Looks to Expand

December 5, 2023

In an expansion of its investigation into suicidal ideation associated with GLP-1 agonists, the European Medicines Agency (EMA) wants manufacturers to answer some undisclosed questions about these drugs, while the popularity of these drugs also continues to expand.

The drugs in EMA’s bull’s eye include Novo Nordisk’s Ozempic (semaglutide), Saxenda (liraglutide), Wegovy (semaglutide), Rybelsus (semaglutide), Victoza (liraglutide), and Xultophy (liraglutide plus basal insulin); Lilly’s Byetta (exenatide); AstraZeneca’s Bydureon (exenatide); Sanofi’s Lyxumia (lixisenatide) and Suliqua (insulin glargine plus lixisenatide); and Lilly’s Trulicity (dulaglutide).

The issue will be discussed again at the April 2024 meeting, the EMA said.

In the meantime, however, the GLP-1 commercial juggernaut continues to plow forward.

Altimmune announced topline results of its 48-week phase 2 obesity trial of pemvidutide showing mean weight loss results of between 10.3 and 15.6 percent, depending on the drug dose. Danuglipron succeeded clinically in the study of adults with co-existing obesity and type 2 diabetes.

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