- By Jason Howland
New Alzheimer’s drug to be submitted to FDA for approval
Drug company Biogen Inc. intends to pursue regulatory approval from the Food and Drug Administration (FDA) for their experimental Alzheimer's drug, aducanumab, based on new analyses of data from their Phase 3 clinical trials. The study results showed reduced decline in people with mild cognitive impairment and mild dementia due to Alzheimer's disease who received the highest dose of the drug over a sufficient period of time.
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.
Journalists: Broadcast-quality sound bites with Dr. Petersen are in the downloads at the end of the post. Please "Courtesy: Mayo Clinic News Network."
"The field of 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 a big step," says Dr. Petersen, who consulted with Biogen on the drug but was not involved in the studies. Mayo Clinic campuses in Rochester, Minnesota, and Jacksonville, Florida, participated in the study.
"This is just approval to file with the FDA. It is not approval of the drug yet. But if it goes forward and it meets the criteria for approval by the FDA, it will constitute a major boost for patients and families," he says.
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.