Tag Archive for: Lecanemab

The European Union’s medicines regulator has delayed it decision on Eisai and partner Biogen’s Alzheimer’s disease drug that was expected this week, the Japanese company said today.

During yesterday’s third-quarter fiscal year 2023 earnings report, Eisai revealed that the launch of its Biogen-partnered Alzheimer’s disease treatment Leqembi (lecanemab) has not been going according to plan, making the company’s goal of treating 10,000 patients by the end of March 2024 appear out of reach.

Subcutaneous injections of Eisai and Biogen’s Leqembi lead to numerically greater amyloid removal than the intravenous version of the Alzheimer’s disease therapy, though risks of brain swelling and bleeding remain.

The 2023 Alzheimer’s Association International Conference will feature further analyses of the recent traditionally approved Leqembi and a highly anticipated update on Eli Lilly’s donanemab.

Last week, an FDA advisory committee gave Eisai and Biogen’s Alzheimer’s drug Leqembi (lecanemab) its unanimous blessing for traditional approval, signaling it will likely become the first drug of its class to receive this classification. While this is positive news for the biopharma partners and Alzheimer’s patients, concerns linger about the drug’s safety and Medicare coverage.

In Europe, where cost-conscious countries rigorously weigh new drugs before adopting their use, nine neurologists and researchers across six countries told Reuters lecanemab is unlikely to be widely used if approved. Their views underpin analyst estimates suggesting Europe will be a small market for the drug.

The Alzheimer’s Association has deployed 1,000 people diagnosed with, or caring for someone with the disease, to meet with all 535 members of Congress across the United States and urge them to press Medicare for early access to a new class of drugs, beginning with lecanemab, that promise to slow the disease.

Japanese drugmaker Eisai Co. Ltd. and its U.S. partner Biogen Inc. said on Monday that the U.S. Food and Drug Administration granted priority review for traditional approval of their Alzheimer’s treatment lecanemab.

The application to the EMA was based on results from a late-stage study that showed the drug slowed down the rate of cognitive decline in patients with early Alzheimer’s by 27%, compared with a placebo.

The past year has seen incremental victories in the neurodegenerative disease space with the approval of Amylyx’s Relyvrio, in ALS and Biogen and Eisai’s Leqembi (lecanemab) in Alzheimer’s disease. Despite these regulatory milestones, there are still hurdles to overcome, with delivery across the blood-brain barrier topping the list.