Biogen, Eisai Request Approval of Aducanumab for Alzheimer’s in Japan

Biogen and Eisai are seeking approval of aducanumab (BIIB037) for the treatment of Alzheimer’s disease in Japan, the companies have announced.

If approved, aducanumab will become the first therapy with the potential to slow the clinical decline seen in patients with Alzheimer’s.

“The filing of the application is an important step in serving patients and their families as aducanumab may help reduce clinical decline and potentially maintain the ability to live an independent life for as long as possible,” said Haruo Naito, MD, CEO at Eisai. “Aducanumab also has the potential to help address the public health challenges our aging population faces in Japan.”

The treatment is under priority review with the U.S. Food and Drug Administration (FDA) with a final decision expected by March 7, 2021. It is also under review with the European Medicines Agency.

“Japan is the third market where we have applied for regulatory approval for aducanumab, and the filing represents continued progress on our commitment to bring this therapy to patients around the world,” Michel Vounatsos, CEO at Biogen, said in a press release.

Aducanumab, being developed by Biogen in collaboration with Eisai, is a man-made antibody designed to clear beta-amyloid protein, whose toxic clumps are known to induce the death of neurons in the brain in those with Alzheimer’s.

The approval requests were based on clinical data from Phase 3 trials — EMERGE (NCT02484547) and ENGAGE (NCT02477800) — which tested aducanumab in people with early Alzheimer’s disease.

The trials were discontinued after an independent monitoring committee determined that aducanumab was not likely to produce meaningful benefits. However, an analysis of an additional three months of data, which became available after the trials stopped, showed that EMERGE achieved its main goal: treatment with aducanumab led to improvements in cognition and function — including memory, orientation, and language, as well as activities of daily living — when compared to a placebo.

ENGAGE failed to meet its primary goal of showing that treatment led to a decline in the progression of cognitive and functional impairments, as assessed by the Clinical Dementia Rating-Sum of Boxes score. However, further analysis found significant benefits in a group of patients exposed to a high dose of aducanumab.

Also, data from an earlier Phase 1b trial, called PRIME (NCT01677572), suggested that aducanumab could slow cognitive decline.

Recently, an advisory arm of the FDA recommended that the available clinical data on aducanumab does not support the effectiveness of the investigational therapy for Alzheimer’s.

Out of 11 committee members, eight agreed that the Phase 3 EMERGE data did not provide “strong evidence” of efficacy, while seven members did not agree that the PRIME study showed enough evidence supporting effectiveness.

FDA advisory committees provide non-binding recommendations to the regulatory agency for consideration.