Leqembi's European Approval Journey: CHMP Reaffirms Positive Opinion Amid Safety Review

Eisai and Biogen's Alzheimer's Drug Clears Crucial Hurdle

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has reaffirmed its positive opinion on Eisai and Biogen's Alzheimer's disease drug Leqembi (lecanemab), paving the way for potential approval in the European Union. This decision comes after a request from the European Commission to review new safety data that emerged following the CHMP's initial endorsement in November 2024.

Leqembi, an anti-amyloid antibody, is designed to treat adults with mild cognitive impairment or mild dementia due to Alzheimer's disease. The CHMP's recommendation is specifically for patients carrying one or no copy of the ApoE4 gene, as those with two copies face a higher risk of brain swelling or bleeding side effects.

Safety Profile Consistent with Approved Labels

Despite concerns that prompted the additional safety review, Eisai and Biogen reported that Leqembi's safety profile in clinical practice in the United States, Japan, and other countries remains consistent with its approved labels. No new safety signals have been identified, alleviating concerns that led to the European Commission's request for reevaluation.

The reaffirmation of CHMP's positive opinion now moves Leqembi's application forward to the European Commission, which will make the final decision on marketing authorization. If approved, the drug would be available in all 27 EU member states, as well as Norway, Liechtenstein, and Iceland.

Market Implications and Future Prospects

Leqembi's potential European approval could provide a much-needed boost to the drug's sales, which have underperformed since its U.S. launch. In the third quarter of the previous fiscal year, Eisai reported approximately $87.4 million in Leqembi sales globally, with $51 million coming from the U.S. market.

To further enhance the drug's accessibility and appeal, Eisai and Biogen are developing a subcutaneous formulation of Leqembi. This new formulation could reduce the burden on healthcare professionals and patients by allowing for home treatments and fewer hospital visits.

As the pharmaceutical industry awaits the European Commission's final verdict, the reaffirmation of Leqembi's positive opinion by the CHMP marks a significant milestone in the drug's journey towards European approval and its potential to address the growing need for effective Alzheimer's treatments in the region.