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Statement: FDA Must Demand a New Clinical Trial of Experimental Alzheimer’s Disease Treatment Following Inappropriate Collaboration

WASHINGTON, D.C. – Drugmakers Biogen and Eisai today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the companies’ application for the experimental drug aducanumab to treat Alzheimer’s disease after the agency requested more data on the drug. In December, Public Citizen called for an investigation of the unprecedented and inappropriate close collaboration between the Biogen and the FDA during the analysis of data from the key clinical trials of the drug. Dr. Michael Carome, director of Public Citizen’s Health Research Group, released the following statement:

“The FDA must reject the current application for aducanumab and demand that Biogen and Eisai conduct another large, placebo-controlled clinical trial before giving further consideration to approving aducanumab to treat Alzheimer’s disease. Additional flawed statistical analyses of data from the previously conducted trials of the drug will not be sufficient to establish that the drug is effective.

“The prior close collaboration between the FDA and Biogen before and after the submission of the application for aducanumab dangerously compromised the integrity of the FDA’s review. To restore that integrity, the agency must assign staff not involved in the tainted collaborative effort to salvage aducanumab to conduct any further review of the application for approval of the drug.

“Approving aducanumab despite the lack of evidence of effectiveness would raise false hope for millions of Alzheimer’s patients and their families, potentially bankrupt the Medicare program because of the drug’s projected exorbitant price and impede for years the development of other experimental treatments for the disease.”