Eisai Inc.
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The filing of a Biologics License Application for a subcutaneous version of Biogen and Eisai’s Leqembi (lecanemab) has been delayed due to procedural reasons, the companies announced Monday.
Thanks to a rough launch of its Biogen-partnered Alzheimer’s disease treatment, Eisai will likely miss its target of treating 10,000 patients with Leqembi by the end of March 2024.
After winning traditional approval from the U.S. regulator, Eisai’s Alzheimer’s disease therapy Leqembi has seen a sharp increase in patient uptake, with a target of 10,000 patients by March 2024.
Subcutaneous injections of Eisai and Biogen’s Leqembi led to numerically greater amyloid removal than the intravenous version of the Alzheimer’s disease therapy, though risks of brain swelling and bleeding remained.
The losing streak continues for Merck and Eisai with their Keytruda-Lenvima combination failing to improve progression-free survival and overall survival in two late-stage lung cancer studies.
While an initial analysis showed improvements in progression-free survival and objective response rate, a second analysis saw no improvement in overall survival.
Following the full approval of Leqembi, the CMS suggests expanding its coverage of beta-amyloid PET scans, which could improve the uptake of novel Alzheimer’s disease treatments.
Eisai and Biogen announced positive data from a Phase III trial in Alzheimer’s of its drug lecanemab. Still, questions remain about the drug’s implications for the future of Alzheimer’s treatment.
Biogen and Tokyo-based development partner Eisai are embroiled in controversy surrounding their investigational Alzheimer’s drug, aducanumab.
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