Eisai plans to apply for FDA approval of subcutaneous Leqembi by early next year
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.
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, -2.14% 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.
Rates of a potentially serious Leqembi side effect associated with brain swelling were similar between the subcutaneous and IV versions, Biogen and Eisai ESALF, -0.72% said Wednesday. The data were presented at this week’s Clinical Trials on Alzheimer’s Disease conference in Boston.
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