(Bloomberg) -- European drug regulators rejected an Alzheimer’s therapy from Eisai Co. and Biogen Inc., a blow to the companies seeking to expand sales in one of the world’s biggest drug markets.
The European Medicines Agency’s human medicines committee recommended against granting marketing authorization for the companies’ drug, Leqembi. Its effect on delaying cognitive decline “does not counterbalance the risk of serious side effects associated with the medicine,” the committee said Friday in a statement.
The first drug shown to slow progression of Alzheimer’s, the mind-robbing disease that afflicts some 6 million Americans, Leqembi gained full US approval last year. But uptake has been slowed by logistical hurdles. Biogen has been seeking a boost from the product, developed with Japan’s Eisai, as sales of its mainstay multiple sclerosis medications decline.
Biogen fell as much as 7.7% in trading before US markets opened, the most intraday since Feb. 13. Shares of Stockholm-based BioArctic AB, Eisai’s partner for Leqembi commercialization in the Nordic region, fell as much as 36%, their biggest intraday loss since 2018. Eisai’s American depositary receipts fell as much as 8.1%.
Global Perceptions
Brian Abrahams, an analyst at RBC Capital Markets, estimated that Europe makes up about 20% of the potential market for Leqembi. Even if the decision is overturned on appeal, a launch in Europe would be delayed, Abrahams said.
“This is likely to somewhat hamper global perceptions and momentum for the drug and the class,” Abrahams said.
The committee noted the frequent occurrence of swelling and potential bleeding in the brain of patients who received Leqembi. Eisai said in a statement that it was disappointed in the decision and would seek reexamination.
Biogen’s drug has already been approved in several other countries, including Japan, China and Israel. This month, Eli Lilly & Co.’s Alzheimer’s treatment, which works similarly to Biogen’s, was cleared in the US as the second drug to slow progression of the disease.
Brain swelling or bleeding occurred in 36% of patients on Lilly’s drug in the company’s main study, according to the drug’s label. Regular scans are required to monitor for these effects.
(Updates with opening shares in fourth paragraph.)
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