Biogen Inc. and Eisai Co. late Wednesday released new data on their Alzheimer’s treatment Leqembi that may ultimately help bolster uptake of the drug.
Weekly treatment with an experimental subcutaneous formulation of Leqembi, which could be easier to administer than the currently approved biweekly intravenous version, resulted in 14% greater amyloid-plaque removal than the IV treatment after six months, the companies said in a release. Amyloid plaques, a hallmark of Alzheimer’s disease, are protein clumps that can accumulate in the brain and disrupt neurons.
Data on the experimental form of Leqembi have been highly anticipated by investors. The U.S. Food and Drug Administration’s full approval of intravenous Leqembi in July didn’t give Biogen shares
BIIB,
much of a boost, as analysts predicted a slow rollout in part because of the U.S. health system’s limited capacity to administer the biweekly infusions. A subcutaneous option could alleviate any infusion bottlenecks and prove more convenient for patients and caregivers, analysts said.
Looking at Leqembi uptake in late September, Jefferies analysts called it “a little wave right now, but not a swell.” After a slower start, the launch may gather steam by the second half of next year, the analysts wrote.
Rates of a potentially serious Leqembi side effect associated with brain swelling were similar between the subcutaneous and IV versions, Biogen and Eisai
ESALF,
said Wednesday. The data were presented at this week’s Clinical Trials on Alzheimer’s Disease conference in Boston.
Eisai said that it plans to apply for U.S. regulatory approval of the subcutaneous form of Leqembi by the end of March 2024. Eli Lilly & Co.’s
LLY,
experimental Alzheimer’s treatment donanemab, which like Leqembi has been found to slow the progression of the disease, could get FDA approval by the end of this year.
Biogen shares fell 2.1% Wednesday and have dropped 10.9% in the year to date , while Eisai shares fell 0.7% Wednesday and are down 16.1% in the year to date.
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