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The Food and Drug Administration has approved the first new treatment for Alzheimer’s disease in 18 years, a drug called aducanumab, sold under the brand name Aduhelm. The president and CEO of the Alzheimer’s Association, Harry Johns, declared this new drug a victory for those living with Alzheimer’s and their families. However, upon further research, I am cautiously optimistic about this new treatment option. Although the FDA’S approval was just announced, it is already surrounded by controversy.

As it turns out, the FDA’S independent advisory committee overwhelmingly voted in November 2020 against recommending the drug be approved, citing a lack of data to prove that the drug slowed cognitive decline. Several members of the committee also wrote a viewpoint, published in the Journal of the American Medical Association detailing the reasons they voted against approving it. Additionally, scientists from the independent nonprofit Institute for Clinical and Economic Review issued a report in May that concluded the benefits of the medication do not outweigh the risks. Other organizations have come out in opposition as well, such as the American Geriatric Association, which has called the drug’s approval “premature.”

Separate from these reports and statements is that the path to approval has been a somewhat unusual one. The agency granted accelerated approval, which grants patients with a serious disease earlier access because of an expectation of successful results before they are proven. The FDA will require Biogen to prove the benefit in a post-approval trial, or the drug could be withdrawn from the market. It is reassuring that studies and research will still be taking place, especially because Biogen previously halted two phase three clinical trials because their analysis showed it is unlikely to be helpful for patients. Once more data became available, only one trial showed that the drug performed better than a placebo.

While the effectiveness of clearing amyloids in the brain is not in question, there are still many questions surrounding the effectiveness in slowing cognitive decline. Because of the ability to decrease these proteins in the brain, doctors may recommend the medication early on in someone’s diagnosis if they are showing minor dementia symptoms because of Alzheimer’s disease. However, it will not reverse any brain function loss that has already occurred and could even cause side effects.

All medications have risks of side effects, some more serious than others, and Aduhelm is no exception. Its website lists serious side effects, such as temporary swelling and bleeding in the brain, and more minor ones, such as confusion, vision changes, nausea and headaches. Because of these, the company recommends MRI scans while taking the medication.

If the drug does turn out to produce positive results in post-approval trials, there is another hurdle; it may be inaccessible to those who need it most. In a press release to investors, Biogen announced that the cost could be around $56,000 per year, with insurance softening this. That would be in addition to any costs associated with the recommended MRI monitoring.

While any treatment option that enhances the lives of those living with dementia symptoms is a positive sign that progress is being made, much more research needs to be done while we all anxiously wait for science to bring about a better pharmaceutical option for the 6 million Americans currently living with Alzheimer’s disease. While this one is not a home run, that does not mean there won’t be one in the future so, in the meantime, we can and should remain optimistic and Dementia Aware.

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