Biogen Eisai Alzheimer’s drug Leqembi rejected by European regulator

European drug regulators on Friday rejected the Alzheimer’s treatment Leqembi from Biogen and Eisai, creating one other hurdle for the businesses as they scramble to spice up uptake of the therapy within the U.S. 

The European Commission, the EU’s executive body, has a final say in Leqembi’s approval. Nevertheless it almost at all times follows the drug regulator’s recommendations. 

In a statement, Eisai said, it’s “extremely disenchanted” by the regulator’s negative suggestion. The corporate added that it should seek a reexamination of the choice.

Shares of Biogen fell greater than 6% on Friday. Japanese drugmaker Eisai’s stock was essentially flat. 

The U.S. Food and Drug Administration last yr approved Leqembi, which has seen a sluggish rollout on account of bottlenecks related to diagnostic test requirements and regular brain scans, amongst other issues. Leqembi has also won regulatory approvals in other countries similar to Japan, South Korea, China and Israel.

The drug was considered a breakthrough for a progressive disease that has proven notoriously hard to treat. It’s a monoclonal antibody that slows the progression of the disease in patients on the early stages of it. 

The European Medicines Agency’s human medicines committee really useful against granting marketing authorization for Leqembi.

In a press release, the committee said Leqembi’s effect on delaying cognitive decline doesn’t outweigh “the chance of great unintended effects related to the drugs.” The committee specifically pointed to the “frequent occurrence” of brain swelling and bleeding in patients who received the treatment. 

Those unintended effects are related to drugs like Leqembi and one other monoclonal antibody from Eli Lilly called Kisunla, which work by targeting and clearing a toxic plaque within the brain called amyloid, an indicator of Alzheimer’s disease. Kisunla won approval within the U.S. earlier this month. 

Leqembi and Kisunla are milestones within the treatment of Alzheimer’s after three a long time of failed efforts to develop medicines that may fight the fatal disease.

One other ill-fated drug from Biogen and Eisai called Aduhelm struggled to take off within the U.S. after questions around its approval and data. In 2021, the European Medicines Agency rejected Aduhelm. 

Seven million people in Europe reside with the mind-wasting disease, and that figure is predicted to double by 2050, in line with data from the non-profit organization Alzheimer’s Europe.