FDA Advisory Committee Rejects Biogen’s Alzheimer’s Treatment

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Biogen announced on Nov. 6 that the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee voted 1 yes, 8 no, and 2 uncertain on the question, “Does Study 302 (EMERGE), viewed independently and without regard for Study 301 (ENGAGE), provide strong evidence that supports the effectiveness of aducanumab for the treatment of Alzheimer’s disease?” In addition, the committee also voted 0 yes, 7 no and 4 uncertain on the question, “Does Study 103 (PRIME) provide supportive evidence of the effectiveness of aducanumab for the treatment of Alzheimer’s disease?”

When asked, “Has the Applicant presented strong evidence of a pharmacodynamic effect of aducanumab on Alzheimer’s disease pathophysiology?” the committee voted 5 yes, 0 no and 6 uncertain. Finally, the group voted 0 yes, 10 no and 1 uncertain when asked, “In light of the understanding provided by the exploratory analyses of Study 301 and Study 302, along with the results of Study 103 and evidence of a pharmacodynamic effect on Alzheimer’s disease pathophysiology, it is reasonable to consider Study 302 as primary evidence of effectiveness of aducanumab for the treatment of Alzheimer’s disease?”

Aducanumab, also known as BIIB037, is a human monoclonal antibody being investigated for the treatment of Alzheimer’s disease. Researchers believe that the product has the potential to impact underlying disease pathophysiology, slow cognitive and functional decline.

“Biogen thanks the many patients and advocates who shared their personal thoughts and experience at today’s Advisory Committee meeting, reflecting the significant unmet need for a treatment for Alzheimer’s,” said Michel Vounatsos, chief executive officer at Biogen. “We appreciated the opportunity to share our data with the Advisory Committee, and we will continue to work with the FDA as it completes its review of our application.”

With the opinions that were expressed by the advisory committee, along with the data presented, the FDA will continue onward with its review process. It is expected to determine whether to approve the aducanumab Biologics License Application by March 7, 2021.

Back in October, Biogen and Eisai, Co., Ltd. announced that the European Medicines Agency (EMA) had confirmed that it would review a Marketing Authorization Application (MAA) for aducanumab. Biogen and Eisai Co., Ltd. have collaborated on the development and commercialization of the product globally since October 2017.

“There are no treatments available that impact the progression of Alzheimer’s disease by addressing the underlying disease pathology. The potential that aducanumab may hold to effectively reduce the clinical decline brings new hope to people and families living with this devastating disease,” said Dr. Haruo Naito, chief executive officer at Eisai Co., Ltd. “The acceptance of the Marketing Authorization Application in the European Union is an important milestone as we work towards making this potential treatment available around the world.”

The safety and efficacy of aducanumab have been examined in the EMERGE and ENGAGE Phase III studies. The primary objective of the studies was to evaluate the efficacy of monthly doses of aducanumab compared with a placebo.

“Alzheimer’s disease has become a significant and growing burden for societies around the world, and we believe aducanumab represents the first breakthrough that can change the course of this devastating disease,” Vounatsos said at the time of the announcement. “We are committed to working with regulatory authorities worldwide and we look forward to the European Medicines Agency’s review of this application.”

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