New Alzheimer’s Drug Gets FDA Accelerated Approval
Following the results of three separate studies involving 3,482 patients, Aduhelm (aducanumab) was approved (using the accelerated approval pathway) for treating Alzheimer’s disease. The accelerated approval pathway is only used for drugs that can treat a severe or life-threatening illness and provide a significant therapeutic advantage over currently available treatments.
Alzheimer’s causes are unknown, but it is characterized by brain changes, such as neurofibrillary tangles and amyloid plaques, which result in the loss of neurons and their connections. This decrease of neurons alters the person’s ability to think and remember.
Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, expressed her opinion that other currently available medicines only treat Alzheimer’s symptoms. In comparison, Aduhelm is the first Alzheimer’s medication to tackle the disease at its core manner of development.
The studies mentioned above involved double-blind, randomized, placebo-controlled dose-ranging research on Alzheimer’s patients. Patients who received the medication saw a considerable reduction in amyloid-beta plaque that was dose- and time-dependent. In contrast, patients in the control group saw no decrease in amyloid-beta plaque.
Aduhelm’s prescribing data includes a warning for amyloid-related imaging abnormalities (ARIA), which most typically manifest as transitory swelling in brain areas and then disappear over time without causing symptoms. The most common side effects were diarrhea, headaches, confusion, delirium, disorientation, and falls.
The FDA will require Biogen (the makers of Aduhelm) to conduct a new randomized, controlled clinical trial to evaluate the drug’s clinical benefit under the accelerated approval provisions. If the trial fails to verify clinical benefit, the FDA may take steps to revoke the drug’s approval.
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