The US Food and Drug Administration has approved a new starting regimen for the subcutaneous formulation of lecanemab-irmb (Leqembi) in adults with Alzheimer’s disease. The approval marks the first time patients can begin Alzheimer’s disease treatment at home, according to the US Food and Drug Administration.
Lecanemab-irmb is an amyloid beta-directed antibody indicated for the treatment of adult patients with Alzheimer’s disease. Before this approval, treatment was initiated with an intravenous starting dosage regimen, with the option to transition to intravenous or subcutaneous maintenance dosing after 18 months of treatment.
According to the US Food and Drug Administration (FDA), Alzheimer’s disease affects more than 6.5 million Americans. The agency stated that Alzheimer's disease is characterized by amyloid beta plaques and tau tangles that result in the loss of neurons and their connections.
The approval was supported by data from two large randomized, placebo-controlled clinical trials that evaluated intravenous lecanemab-irmb in patients with confirmed amyloid pathology and mild cognitive impairment or mild dementia due to Alzheimer’s disease. In both studies, patients received intravenous lecanemab-irmb at 10 mg/kg every 2 weeks for 18-months, with the option to continue in a longer-term follow-up phase.
The subcutaneous formulation was not evaluated in separate large clinical outcome trials. The FDA stated that the approval was supported by evidence from the intravenous formulation together with findings that the subcutaneous formulation produced comparable pharmacokinetic exposure and similar reductions in amyloid plaques.
The prescribing information includes a boxed warning for amyloid-related imaging abnormalities (ARIA), which are associated with amyloid-targeting antibodies. ARIA may present as temporary brain swelling or small areas of bleeding in or on the surface of the brain and may occur with or without symptoms. Symptoms may include headache, confusion, dizziness, vision changes, and nausea. The prescribing information states that testing for apolipoprotein E ε4 status should be performed before treatment because patients who are homozygous for the apolipoprotein E ε4 allele have a higher incidence of symptomatic, serious, and severe ARIA.
The most common adverse reactions are headache, infusion-related reactions, and ARIA. The subcutaneous formulation is also associated with injection-site reactions, including redness, swelling, rash, pain, and bruising. The prescribing information also recommends caution when considering lecanemab-irmb in patients receiving anticoagulants because of an increased risk of intracerebral hemorrhage. Lecanemab-irmb is contraindicated in patients with serious hypersensitivity to lecanemab-irmb or its inactive ingredients. The application received Priority Review, and the approval was granted to Eisai Inc.
Source: US Food and Drug Administration
