Fri Nov 15 03:27:51 UTC 2024: ## EU Regulators Reverse Decision, Recommending Alzheimer’s Drug Leqembi for Limited Use
**Amsterdam, November 15, 2024:** The European Union’s drug regulator, the Committee for Human Medicinal Products (CHMP), has recommended approval of Eisai and Biogen’s Alzheimer’s drug Leqembi for a specific subset of patients with early-stage Alzheimer’s disease. This decision marks a significant reversal from the regulator’s initial rejection of the drug in July.
The CHMP’s recommendation, if accepted by the European Commission, would make Leqembi the EU’s first approved treatment for the debilitating disease. However, the drug’s use would be limited to patients who have one or no copies of the ApoE4 gene variant, a genetic marker associated with earlier onset of Alzheimer’s.
In its original assessment, the regulator had cited concerns about the risk of serious brain swelling associated with Leqembi, outweighing the drug’s modest benefits in slowing cognitive decline. However, upon re-examination, the CHMP determined that patients with one or no copies of the ApoE4 gene variant experienced less severe side effects, including brain swelling and potential bleeding, making the drug’s benefits outweigh the risks in this group.
This decision represents a cautious approach to the use of Leqembi, focusing on those patients most likely to benefit from the drug while minimizing potential risks. The final decision on the drug’s approval rests with the European Commission, which will likely make its decision in the coming weeks.
First Piper 