Aduhelm, a new Biogen drug, received approval from the U.S. Food and Drug Administration (FDA) last week, with the hope that it will be a game-changer when it comes to caring for dementia patients. It is the first federally-approved drug that works to slow the biological process of Alzheimer’s instead of simply alleviate the symptoms.
Advocates believe that Aduhelm can slow disease progression, ultimately turning Alzheimer’s into a manageable chronic condition. Proponents, however, argue that the scientific evidence fails to support the claims of the drug. Considering this lack of evidence, they also balk at the $56,000 price tag on a year’s worth of treatment.
Scientists have expressed shock towards the FDA’s decision, especially because the agency ignored an outside advisory committee that voted almost unanimously against approval. Harvard Medical School Professor Aaron Kesselheim was one of three committee members who resigned in protest. He called the decision “probably the worst drug approval…in recent U.S. history.”
Widespread Reach of Aduhelm’s Approval
The cost of Aduhelm, coupled with the number of Americans who could end up using the drug, may have an even more widespread reach and play a role in the ongoing debate about reforming the FDA and enacting legislation to drive down the price of prescription drugs. Industry advocates worry that giving the government more power within the pharmaceutical industry will result in fewer medical breakthroughs. However, Aduhelm’s approval may show this line of thinking to be flawed. The FDA’s concerning approval of the drug may result in less productive future research, a longer wait for successful Alzheimer’s treatment, and more difficulties in funding programs that these patients and their families need.
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Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.