FDA to Decide on Lecanemab’s Approval in January 2023

Potential Alzheimer's therapy up for accelerated approval in US

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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A young man shouts an announcement into a megaphone.

The U.S. Food and Drug Administration (FDA) has agreed to review an application from Eisai seeking accelerated approval of lecanemab (BAN2401), an investigational amyloid-targeting antibody to treat early Alzheimer’s disease in people with confirmed amyloid plaques in the brain.

Eisai finished the rolling application a few months ago. The FDA has granted the application priority review and is expected to make a decision by Jan. 6, 2023.

“The acceptance of lecanemab’s BLA [biologics license application] with priority review is an important milestone in serving people living with Alzheimer’s disease who have been waiting for new treatment options to address an underlying pathology of Alzheimer’s disease,” Haruo Naito, Eisai’s CEO, said in a press release.

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Through its accelerated approval pathway, the FDA can give conditional approval to therapies based on early clinical data from biomarkers that indicate a therapy is likely to be effective. When a therapy is given conditional approval, its manufacturers are allowed to market the therapy in the U.S., but they are also required to conduct additional testing to confirm its efficacy.

Eisai is seeking accelerated approval to make lecanemab available to patients as quickly as possible. Of note, another amyloid-targeting therapy co-developed  by Eisai and Biogen, Aduhelm (aducanumab), was granted accelerated approval by the FDA in 2021.

“We will continue to actively cooperate with the FDA’s review in an effort to bring this new treatment option to people living with Alzheimer’s disease and their families as soon as possible,” Naito said.

Nearly all cases of Alzheimer’s disease are characterized by the presence of amyloid plaques, which are abnormal tangles or clumps of proteins in the brain that are thought to drive the disease. Lecanemab is designed to clear these disease-associated plaques. The experimental therapy was co-developed by Eisai in collaboration with BioArctic and Biogen.

“Together with Eisai, we are committed to continuing our work to address the tremendous unmet need for these patients and their families,” said Michel Vounatsos, Biogen’s CEO.

“We believe in a future where people living with Alzheimer’s disease will have different treatment options to address this complex disease, and today’s BLA acceptance with priority review by FDA is an important step towards this vision,” Vounatsos added.

The lecanemab BLA is supported by data from a Phase 2b clinical trial called Study 201 (NCT01767311), which enrolled more than 850 people with early Alzheimer’s. Study results demonstrated that the therapy could clear amyloid plaques.

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The application also includes data from the ongoing Clarity AD Phase 3 trial (NCT03887455), which is testing lecanemab against a placebo in 1,795 people with early Alzheimer’s. The study’s main goal is to evaluate the effect of treatment on changes in a measure of dementia symptoms called the CDR-SB.

Efficacy data from the Clarity AD trial are expected to become available this autumn. The FDA has agreed that results of the trial will be sufficient to serve as a confirmatory study of lecanemab’s effectiveness and, assuming that results are positive, Eisai is planning to apply for traditional approval of lecanemab by March of next year.

Eisai has begun the process of seeking lecanemab’s approval in Japan. The company plans to apply for approval of lecanemab in Europe after data from Clarity AD become available.