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The company that makes aducanumab for Alzheimer's disease says that the drug slows mental decline. Biogen Inc. revealed its new analyses of data from its phase 3 clinical trials at the Clinical Trials on Alzheimer's Disease conference in San Diego.
Biogen had discontinued two clinical trials for the drug in March, but reversed the decision in October. That's when it announced it would apply for regulatory approval from the Food and Drug Administration.
Dr. Ronald Petersen, director of the Alzheimer's Disease Research Center at Mayo Clinic, says aducanumab targets the amyloid plaques in the brain that are believed to be an essential component of Alzheimer's disease.
He moderated a panel discussion, after today's presentation. "One of the studies was positive and one was negative," says Dr. Petersen. "When they did a post hoc study, they came up with an explanation why the negative study failed." He adds, "The positive side of this is that it's really the first study to show significant clinical effect of an amyloid lowering drug."
Dr. Petersen says this is a pivotal time in the field. "Alzheimer's disease research is at a low point right now with regard to therapeutics. We've had many drug failures. Recently, a whole class of drugs has shown to be ineffective in treating the disease — maybe even causing some harm. So the fact that this drug class — the antibodies against amyloid — may be effective at removing the amyloid from the brain and stabilizing people clinically is encouraging."
Dr. Petersen is the Cora Kanow professor of Alzheimer's Disease Research and the Chester and Debbie Cadieux director of Mayo Clinic Alzheimer's Disease Research Center. He consulted with Biogen Inc. on the drug, but he was not involved in the studies.
Mayo Clinic in Florida and Minnesota participated in the studies.