Biogen’s Alzheimer’s Drug Turned Down by Independent Panel
After receiving promising comments from the FDA staff only days ago, Biogen wouldn’t have expected the agency’s Peripheral and Central Nervous System Drugs Advisory Committee to reject its Alzheimer’s drug, aducanumab. The panel voted 8-1 (2 uncertain), claiming that the EMERGE trial does not provide strong evidence supporting aducanumab’s effectiveness for Alzheimer’s Disease treatment.
When asked if the PRIME trial data demonstrated the drug’s efficacy, the panel voted 0-7 (4 uncertain). However, 5 members from the panel said yes to the question, “Has the Applicant presented strong evidence of a pharmacodynamic effect of aducanumab on Alzheimer’s disease pathophysiology?” while 6 panelists were uncertain. In light of all these discussions, 10 out of 11 members disagreed that the EMERGE trial data can be used as primary evidence of the effectiveness of aducanumab.
“Alzheimer’s treatment is a huge, urgent, unmet need,” said panelist Dr. Joel Perlmutter, of Washington University School of Medicine. “But if we approve something with data that is not strong, we have the risk of delaying good, effective treatments.”
Shares of Biogen (BIIB) were halted on Friday in advance of the meeting, but the panel’s verdict is expected to impact its stocks once the halt is removed. However, the stocks of Eisai dropped from $99.12 to $83 per share within minutes of the announcement.
“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, CEO of Biogen in a statement. “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.”
If the FDA still approves the drug, aducanumab will become the first authorized drug to slow cognitive decline in patients and mark a milestone in Alzheimer’s Disease treatment in nearly 20 years. However, the panel’s rejection would be a strong deterrent, and most probably, Biogen would be asked to conduct another study to provide clear evidence for aducanumab’s effectiveness.
By Rajaneesh K. Gopinath, Ph.D.
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