EU medicines regulator rejects Eisai-Biogen Alzheimer's drug

[July 26, 2024]  (Reuters) -The European Union's drugs regulator has rejected Eisai and Biogen's breakthrough treatment for early Alzheimer's disease, it said on Friday, in a blow to the drugmakers as take-up in the U.S. has been slower than expected.

The agency's Committee for Medicinal Products for Human Use had recommended not granting an authorization as the observed benefits did not counterbalance the risk of serious side events, especially brain swelling and bleeding or microhemorrhages.

In clinical trials, the drug slowed cognitive decline by 27% in early Alzheimer's patients, compared with a placebo.

"The seriousness of this side effect should be considered in the context of the small effect seen with the medicine," the regulator said.

Biogen and Eisai did not immediately respond to Reuters requests for comment. Biogen's shares fell 5.5% to $215 in US premarket trading.

The recommendation has to be formally backed by the European Commission, which usually follows the regulator's decision automatically.

A March 21 hearing of the committee to discuss the drug was delayed due to structural changes within the agency, Eisai had said. The drug has been under review in the region since January 2023 and gained traditional approval in the U.S. last year.

A treatment for Alzheimer's disease has eluded drugmakers for decades. Another Eisai-Biogen drug called Aduhelm failed to take off in the U.S. after questions over its approval and data, and was never approved in Europe.

The Alzheimer's drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. Eisai/Handout via REUTERS/File Photo

In Europe, seven million people are living with the brain-wasting disease, and that figure is expected to double by 2050, according to Alzheimer's Europe, a non-profit organization.

The drug, lecanemab, is sold as Leqembi in the U.S. and was set to be Europe's first drug to treat the neurodegenerative condition rather than its symptoms.

Leqembi's U.S. launch has so far been lackluster, with bottlenecks due to its requirements such as additional diagnostic tests, twice-monthly infusions and regular brain scans.

The U.S. Food and Drug Administration had on July 2 approved Eli Lilly's Alzheimer's drug Kisunla. Unlike Leqembi, Kinsula requires finite dosing, which allows patients to stop taking the treatment once brain scans no longer show amyloid plaques.

(Reporting by Manas Mishra and Puyaan Singh in Bengaluru; Editing by Josephine Mason and Arun Koyyur)

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