Biogen IncFDA approved subcutaneous starter dose of Leqembi, a new formulation that improves convenience.
Biogen shares rose nearly 5% after the FDA approved a subcutaneous autoinjector version of Leqembi as an initiation dosing option for early Alzheimer's disease. The new formulation, marketed as Leqembi Iqlik, allows patients to start treatment with a once-weekly injection that takes about 15 seconds, eliminating the need for biweekly hour-long intravenous infusions during the initiation phase. Biogen plans to launch the product commercially by the end of next month. The approval is supported by clinical data showing drug exposure equivalent to the intravenous version. Leqembi, developed in collaboration with Japan-based Eisai, was initially approved in 2023 as a biweekly intravenous medication.
Biogen IncFDA approved subcutaneous starter dose of Leqembi, a new formulation that improves convenience.
Eisai is Biogen's collaborator on Leqembi, so approval benefits Eisai as well.
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