Credit: Envato Elements
Biogen and Eisai today announced that the European Medicines Agency (EMA) has not recommended approval for their Alzheimer’s treatment, Leqembi. This decision comes as a significant setback for the therapy, which has already been approved in the United States, Japan, South Korea, China, and Israel.
The EMA’s human medicines committee concluded that the risks of Leqembi, particularly the “frequent occurrence” of brain swelling and bleeding observed in patients, outweigh its benefits in delaying cognitive decline. This decision contradicts the approvals granted by several other international regulatory bodies based on the same clinical data.
Eisai, the lead developer of Leqembi, expressed its disappointment with the EMA’s decision. “We are extremely disappointed by the EMA’s negative recommendation and plan to seek a reexamination of this decision promptly,” said Dr. Haruo Naito, CEO of Eisai.
Biogen shares experienced a decline of more than 6% following the news, reflecting investor concerns over the commercial viability of Leqembi in the European market. Conversely, Eisai’s stock remained largely unaffected.
Leqembi represents a class of drugs that target amyloid plaques in the brain, a common hallmark of Alzheimer’s disease. Despite the challenges, these drugs, including Eli Lilly’s recently approved Kisunla, are seen as significant advancements in treating a disease that affects millions worldwide.
“We remain committed to the Alzheimer’s community and believe in Leqembi’s potential to make a meaningful difference for patients suffering from this devastating disease,” Dr. Naito added.
Biogen and Eisai are preparing for the next steps following the EMA’s decision and will continue to work closely with regulatory authorities to make Leqembi available to patients across the globe.
