Eli Lilly (LLY) failed to get a recommendation from the European Medicines Agency for its application to extend the use of Mounjaro to treat heart failure with preserved ejection fraction in adults with obesity, the regulator said Friday.
The agency said there is no need for a separate indication for the treatment of adults with chronic HFpEF and obesity, although it agreed to include relevant data from the submitted study in Mounjaro's product information.
Based on the results from the main study, the regulator said Mounjaro significantly lowered hospitalizations due to heart failure and improved patients' quality of life, although it did not reduce deaths related to heart and blood circulation in adults with obesity and HFpEF.
"Uncertainty remains as to whether these results are a weight-loss-independent effect of Mounjaro and that the use of Mounjaro in this group of people is already covered by the approved indication for weight management," the regulator said.
Mounjaro is currently approved in the European Union as treatment for type 2 diabetes. It is also used to help people with obesity lose weight and keep their weight under control, the EMA said.
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