By Fineline Cube 
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion last week regarding the approval of Eli Lilly and Company’s (NYSE: LLY) Kisunla (donanemab) for the treatment of early Alzheimer’s disease (AD). Despite this setback, the US pharmaceutical giant stated that it will seek a review from the CHMP and expressed confidence in the safety and efficacy of donanemab.
Donanemab’s Unique Profile
Donanemab is the world’s third anti-amyloid therapy following Biogen/Eisai’s aducanumab (now discontinued) and Eisai’s Leqembi (lecanemab). A distinctive feature of donanemab is that it can be discontinued when PET imaging indicates that amyloid plaques have been reduced to the lowest level. This sets it apart from the other two therapies, which do not offer the same flexibility.
Global Approval Status
Kisunla has already secured marketing approvals in the US, Japan, and China in July, September, and December of last year, respectively. These approvals highlight the drug’s recognized potential in addressing the unmet needs of Alzheimer’s patients outside the European market.
Lilly’s Response
Eli Lilly remains committed to advancing donanemab as a treatment option for Alzheimer’s disease and is actively pursuing a review of the CHMP’s decision. The company’s confidence in the therapy is based on extensive clinical data demonstrating its positive impact on patients.-Fineline Info & Tech