Biogen Wins FDA Approval for Subcutaneous Starter Dose of Leqembi
Article excerpt
Shares of Biogen BIIB rose nearly 5% yesterday after the company announced that the FDA approved a subcutaneous (SC) autoinjector version of Leqembi as an initiation dosing option for the treatment of early Alzheimer's disease (AD). The SC version of the drug is marketed under the brand name Leqembi Iqlik. Previously, patients initiating Leqembi therapy were required to receive intravenous (IV) infusions once every two weeks for 18 months before transitioning to monthly IV maintenance dosing or weekly SC maintenance dosing. With the latest approval, patients now start treatment with a once-weekly SC autoinjector, eliminating the need for biweekly IV infusions during the initiation phase. The new option provides relief to AD patients taking Leqembi, as IV administrations are time-consuming, nearly one hour for each infusion. According to Biogen, this SC version can be administered in about 15 seconds and can even be used by patients at home or in medical centers. Patients may also switch from IV to SC administration or vice versa, providing greater convenience and flexibility in Leqembi administration. The latest approval marks an important milestone for Leqembi, as patients can now receive the entire course of treatment through the SC formulation, including at-home administration, if appropriate. While Leqembi Iqlik requires weekly administration, it can be delivered in...
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Recently, Biogen made headlines after deciding to advance its experimental tau-targeting therapy, diranersen, into late-stage development despite the candidate missing the primary endpoint in a mid-stage study.