FDA Approves Subcutaneous Injection for Maintenance Treatment of Early AD
On August 29, the US Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for once-weekly subcutaneous lecanemab-irmb injections (LEQEMBI IQLIK) for the maintenance treatment of early Alzheimer disease (AD). Developed by Eisai Co., Ltd. and Biogen Inc., the injection is indicated for use in adults with mild cognitive impairment (MCI) or mild dementia stage of disease who have undergone 18 months of lecanemab-irmb intravenous (IV) treatment. The newly approved autoinjector provides an alternative to the IV maintenance regimen of 10 mg/kg every 4 weeks.
The approval was supported by results from the subcutaneous sub-studies of the Phase 3 Clarity AD open-label extension trial in individuals with early AD. Data reported that weekly lecanemab-irmb injections following 18 months of the initiation dose (10 mg/kg IV every 2 weeks) maintained clinical and biomarker benefits comparable to IV maintenance treatment. The safety profile of the injection was also comparable to that of continued IV dosing, though systemic reactions were less common in subcutaneous dosing.
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Amyloid-related imaging abnormalities (ARIA) rates in patients who received a subcutaneous maintenance dose were also similar to those who received a continued IV dose. LEQEMBI carries a black box warning for ARIA, which may be asymptomatic but can present with edema, microhemorrhage, or rarely fatal intracerebral hemorrhage. Risk is higher in ApoE ε4 homozygotes, warranting genetic testing and enhanced MRI monitoring during the first 14 weeks.
The drug is also contraindicated in patients with serious hypersensitivity to lecanemab-irmb or its excipients.
The autoinjector is the first anti-amyloid treatment approved for home administration by a patient or caregiver, expanding treatment options with the potential to reduce infusion center burden and improve adherence.
