Biogen's stock stumbles as Alzheimer's drug is rejected by European regulators

By Eleanor Laise

Drug's benefits don't outweigh the risk of potentially severe brain swelling and bleeding, regulator says

Biogen Inc.'s stock fell more than 6% premarket on Friday after European regulators gave a thumbs down to the company's Alzheimer's disease treatment, which it markets jointly with Eisai Co. Ltd.

The European Medicines Agency's Committee for Medicinal Products for Human Use recommended not granting marketing authorization for the Alzheimer's drug, Leqembi, which gained full U.S. regulatory approval last year. Leqembi's effect on delaying cognitive decline "does not counterbalance the risk of serious side events associated with the medicine," the agency said in a statement on its website, pointing in particular to the "frequent occurrence" of side effects involving brain swelling and bleeding.

Those concerns echo the safety issues raised by advisers to the U.S. Food and Drug Administration at meetings reviewing Leqembi as well as Eli Lilly & Co.'s (LLY) new Alzheimer's drug Kisunla, which the FDA approved early this month.

Examining the benefits of Leqembi, the European regulatory committee noted that patients taking the drug had improved scores on a dementia rating scale, compared with those on placebo, but "the difference between the two groups was small." The seriousness of the potential brain swelling and bleeding, the committee said, "should be considered in the context of the small effect seen with the medicine."

"We are extremely disappointed" by the European regulator's negative opinion on Leqembi, Lynn Kramer, chief clinical officer at Eisai, said in a statement. "There is a significant unmet need for new innovative treatment options that target an underlying cause of disease progression," Kramer said.

Eisai (ESALF), which takes the lead on regulatory matters for Leqembi, will seek re-examination of the opinion and work with regulators to ensure the treatment is available for people in the European Union with early Alzheimer's disease "as soon as possible," Biogen and Eisai said in a release Friday.

Beyond the U.S., Leqembi is also approved in Japan, China, South Korea, Hong Kong and Israel.

Biogen shares (BIIB) are down 12.1% in the year to date, while the S&P 500 SPX is up 13.2%.

-Eleanor Laise

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07-26-24 0806ET

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