FDA approves monthly maintenance dosing for Leqembi

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The U.S. Food and Drug Administration (FDA) has approved Eisai and Biogen's Alzheimer's disease (AD) drug Leqembi for a monthly maintenance dose schedule after initial treatment.

Leqembi, an IV therapy which works through clearing amyloid-beta (Aβ) plaque from the brain along with protofibrils that contribute to neuronal injury, was approved by the FDA in 2023 for the treatment of early-stage AD in patients with mild cognitive impairment or in the mild dementia stage of the disease.

In a statement, Eisiai and Biogen noted that the maintenance-dose schedule of once every four weeks may be considered after the patient has completed the initial 18-month course of treatments every two weeks. The maintenance dosing schedule was based on findings from both phase II and phase III studies, along with their long-term extensions, the firms said. They noted that modeling simulations predicted that the transition to maintenance dosing after 18 months of the initial treatment will maintain Leqembi's clinical and biomarker benefits.

The companies stressed that AD progression does not stop after plaque clearance, with the protofibrils continuing to damage neurons in the brain. In the trials, discontinuation of treatment was associated with the reaccumulation of Aβ plaque and biomarkers; thus, the need for a maintenance dose.

In addition, the FDA accepted Eisai's supplemental biologics license for the Leqembi subcutaneous autoinjector for weekly maintenance dosing; the FDA has set a prescription drug user fee amendment action date for August 31.

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