FDA acknowledged evidence of efficacy of lecanemab-irmb drug

Lecanemab-irmb is designed to treat patients with Alzheimer's disease. It works by reducing amyloid plaques in the brain, which are a characteristic pathophysiological feature of the disease.

Lecanemab-irmb was first approved in the U.S. in January 2023 under an accelerated approval process. This pathway allows the FDA to approve drugs for serious conditions for which there is no treatment yet, based on clinical data showing the drug's impact on a surrogate endpoint - in the case of lecanemab-irmb, this is the reduction of amyloid plaques in the brain - which is highly likely to predict clinical benefit for patients.

As a condition for accelerated approval, the FDA required the applicant to conduct a confirmatory clinical trial to verify the anticipated clinical benefit. Study 301 was a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial that enrolled 1,795 patients with Alzheimer's disease.

Treatment was initiated in patients with mild cognitive impairment or mild dementia of disease and confirmed amyloid beta pathology. Patients were randomly divided 1:1 into a group receiving placebo or lecanemab-irmb at a dose of 10 mg/kg once every two weeks. Lecanemab-irmb showed statistically significant and clinically meaningful improvement from baseline to 18 months as assessed by the primary endpoint, the Clinical Dementia Rating Scale total score, compared to placebo. Statistically significant differences between the treatment groups were also demonstrated in all endpoints.

In June, the FDA convened the Peripheral and Central Nervous System Drug Advisory Committee to discuss whether Study 301 provided evidence of clinical benefit for the drug lecanemab-irmb for the treatment of Alzheimer's disease. All committee members voted in favor of whether the results of the study supported the clinical benefit of lecanemab-irmb for the indicated use.

Source: FDA