Publication date: Jun 08, 2021
If aducanumab were approved, critics contended, it would have made it hard to recruit Alzheimer’s patients for clinical trials for other drugs where some volunteers would get a placebo. -Aduhelm is the first novel therapy approved for Alzheimer’s disease since 2003,” Dr. Patricia Cavazzoni, director of the FDA Center for Drug Evaluation and Research, said in a statement. Nonetheless, Biogen concluded that aducanumab slowed cognitive decline and that the key to effectiveness was giving patients a high enough dose. Those drugs typically delay the decline for several months, and none address the underlying causes of the disease, as aducanumab is meant to do. The ruling is certain to be cheered by Alzheimer’s patients, their families, and advocates who have hungered for a drug more effective than the five previously approved. Patients are expected to receive the drug intravenously for about an hour every four weeks, unlike older drugs like Namenda and Aricept, which come in pill form. Aducanumab is a monoclonal antibody made from the immune cells of older people with no or uncommonly slow cognitive decline.
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