(Bloomberg) -- Eisai Co. and its partners won the European Union regulator’s backing for use of its Alzheimer’s drug Leqembi in a surprising reversal of a previously negative opinion.
The European Medicines Agency’s drug advisory panel said on Thursday that a re-examination of its initial negative decision had shown that the benefits of the drug outweighed the risks in a restricted pool of patients.
Leqembi should be limited to patients with one or no copy of the gene variant ApoE4, the panel said. The gene variant is linked to a higher risk of Alzheimer’s disease, and people with two copies of ApoE4 are also more likely to experience brain swelling and bleeding on the drug than those with one or none. About one in 50 people in the US have two copies of the variant, researchers estimate.
The decision marks a win for the Japanese company and its partners Biogen Inc. and Stockholm-based BioArctic AB, which has the right to commercialize Leqembi in the Nordic region.
Biogen’s shares rose 6.1%, before shedding gains, while Eisai’s American depositary receipts rose as much as 14% before paring back.
The decision is “a significant step forward in the fight against Alzheimer’s disease,” Priya Singhal, Biogen’s head of development, said in a statement. Approval in Europe will benefit millions of patients, she said.
Europe’s advisory panel had previously recommended against granting market authorization for the medicine in July, saying risks — such as brain bleeding — outweighed benefits. Use of Leqembi in Europe will involve controlled access programs to make sure only the patients who are recommended to get the drug receive it, the agency said Thursday.
Leqembi has already received approval in countries including Japan, China and the US, though uncertainty over insurance as well as complicated safety-monitoring requirements have slowed down its launch. Eisai cut its forecast for Leqembi last week.
Europe may account for up to 30% of Leqembi’s worldwide peak sales, said Michael Yee, an analyst at Jefferies.
The drug has been shown to slow progression of Alzheimer’s, the mind-robbing disease that afflicts some 6 million Americans. It works by reducing the brain amyloid levels in patients in the early stages of the disease. In the final-stage patient trial of the drug, about 15% of patients had two copies of the ApoE4 gene, while more than half had one copy.
Rival Eli Lilly & Co. is developing a similar drug branded Kisunla.
Read: What You Should Know About Newest Alzheimer’s Drugs: QuickTake
--With assistance from Robert Langreth, Michelle Fay Cortez, Gerry Smith and Lisa Pham.
(Updates with Biogen executive comment in the fifth paragraph)
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