Did the FDA Grant Approval to Aducanumab for Alzheimer’s Disease Prematurely?
The FDA has granted accelerated approval to aducanumab for the treatment of Alzheimer’s disease, which has caused a great deal of debate in the scientific community. The approval was based on 2 phase 3 clinical trials -- one met the primary endpoint, showing a reduction in clinical decline, but the other did not. However, in all studies in which it was evaluated, aducanumab consistently and very convincingly reduced the level of amyloid plaques in the brain in a dose- and time-dependent fashion. Despite this, some say that data is incomplete, as phase 2 trials were skipped. There is also concern that futility analyses had contradictory results.
The FDA approval of aducanumab for Alzheimer’s disease has sparked debate. Studies show that it reduces amyloid plaques in the brain, but the data is incomplete and contradictory. Are you for or against the approval of aducanumab for Alzheimer’s disease?
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