The drug Aduhelm (generic: aducanumab), when first introduced, was touted as a miracle drug for the treatment of Alzheimer’s disease. In fact, a drug that could treat the underlying biology that causes Alzheimer’s disease would be a miracle for the 50 million people living with the disease. Because of promising preliminary data generated by the U.S. based biotech company Biogen, who developed the drug in collaboration with the Japanese pharmaceutical company Eisai, the U.S. Food and Drug Administration (FDA) granted Aduhelm accelerated approval in June 2021. Since then, however, the drug has faced controversy and backlash that has led to poor sales and skepticism among health care providers and patients.
Aduhelm was designed and developed as an antibody-based immunotherapy that could react with amyloid-beta (Ab) aggregates and remove the aggregates from the brain. A prevailing hypothesis for the cause of Alzheimer’s disease, called the Amyloid-bhypothesis, is that the memory and cognitive impairments typically seen in patients with Alzheimer’s disease is caused by Abthat accumulates in the brain to form plaques which disrupt normal cell-to-cell communication.
The initial studies on the drug claimed to show a significant decrease in the concentration of Ab in the brain following one year of administration of Aduhelm compared to placebo controls. However, the clinical effects of the drug were uncertain as the drug only improved memory and cognition marginally and on a subset of tests. Because of this, many questions remained regarding the purported effectiveness of the drug.
Now, in further trouble for the drug and Biogen, the U.S. Centers for Medicare and Medicaid Services (CMS) announced that government sponsored health insurance would only cover the cost of the drug if patients were enrolled in clinical trials. As such, this will significantly limit the number of individuals who would be able to afford the costly drug treatment. This follows news out of Japan and Europe, where regulators have yet to approve the drug for market to the general public.
Biogen and the Alzheimer’s Association have both issued strong rebukes against these decision saying that access to this critical treatment will be severely limited to only a select group of people. Regardless, Biogen continues to push forward with further clinical trials and paperwork to regulatory agencies in the hope that they can treat more Alzheimer’s disease patients with their drug.