Biogen’s shares rose nearly 5% following the FDA’s approval of a subcutaneous autoinjector version of Leqembi for treating early Alzheimer’s disease. This new version, marketed as Leqembi Iqlik, allows patients to start treatment with a once-weekly autoinjector, eliminating the previous requirement for biweekly intravenous infusions. The approval marks a significant enhancement in treatment convenience, allowing administration in approximately 15 seconds compared to the hour-long infusions.
The FDA’s endorsement is based on clinical data indicating equivalent drug exposure with the new weekly dosing regimen compared to the traditional intravenous route. Biogen plans to commercially launch the autoinjector version by the end of next month. Leqembi is co-developed with Eisai, which retains final decision-making authority.
Year-to-date, Biogen’s stock has increased by 19%, outperforming the industry average growth of 2%. The company is also advancing its experimental tau-targeting therapy, diranersen, into late-stage development despite mixed results in a prior study.
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