The Food and Drug Administration's (FDA) approval of aducanumab [marketed as Aduhelm] for the treatment of Alzheimer's disease was greeted with both hope and concern. Hope, because Alzheimer's disease has evaded effective treatment for decades, and because this new treatment brings great promise for the six million Americans afflicted with this devastating illness. Concern, because the data and research that served as the basis for the approval raises significant doubt about the effectiveness and safety of the drug.
Prior to the FDA’s approval, standard treatments for Alzheimer’s included drugs such as donepezil [marketed as Aricept], which presented modest improvements in cognition, day-to-day activities, and behavior in some people. This class of medicines, however, has never been shown to completely stop the steady loss of function associated with Alzheimer’s.
A new approach to Alzheimer's
Aducanumab presents a new and different approach. It is a monoclonal antibody administered intravenously that targets amyloid, a protein often found in elevated levels in the brains of people with Alzheimer’s. While the drug has been effective at consistently removing amyloid from the brain, the clinical findings of those who underwent treatment with aducanumab were not as promising. In the two studies performed by the drug maker—each with a low-dose and a high-dose cohort—the drug proved effective in just one of the two high-dose groups by reducing symptoms at a statistically significant level. The two low-dose groups and the other high-dose group showed no measurable benefit.
These findings raise the question as to whether lowering levels of amyloid protein in the brain is an effective way to treat Alzheimer’s and predict clinical improvement. To date, there is limited—if any—substantial evidence to support the relation between amyloid and Alzheimer’s. In addition, more than one in three patients with Alzheimer’s do not have elevated amyloid in the brain, so there’s no expectation that they would benefit from the drug. Aducanumab is associated with side effects such as headache, balance problems, and disorientation—some of which may be related to swelling and bleeding in the brain.
The projected cost of a one-year aducanumab treatment is $56,000—potentially reaching $100,000—given the additional costs of facility charges and necessary laboratory and imaging tests. Given the high cost and limited, if any, clinical benefits, some insurers have already indicated they will not cover the drug. Strikingly, some prestigious providers, including the Cleveland Clinic and Mt. Sinai in New York, have announced they will not administer the drug at all due to the minimal clinical benefit and safety concerns.
Nevertheless, since the impact of Alzheimer’s can be severe, the FDA accepted the removal of amyloid from the brain and the clinical benefit in one of four studied groups as a sufficient reason to approve the drug. The regulators also took into consideration the vocalized support of aducanumab by patients and professional organizations, such as the Alzheimer’s Association. The approval is limited to patients in the mild dementia stage and the manufacturer, Biogen, is required to conduct further studies.
Reason for optimism
Even with all the caveats and narrow opportunity associated with this drug, it is with great optimism that we anticipate more effective Alzheimer’s treatments in the near future.
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