In less than two weeks since winning an FDA approval, Biogen has already lined up the first patient outside of a clinical trial to receive aducanumab — the hotly debated Alzheimer’s treatment.
Today, a patient in Rhode Island is set to receive the first infusion of Aduhelm (aducanumab). Although the FDA approved the treatment for any patient with Alzheimer’s, clinical testing focused on those in the early stages of the disease — and in the U.S., people considered to be in the early stages account for about 1.5 million of the 6 million Alzheimer’s patients.
The controversy surrounding aducanumab, which began last year, has only increased since its June 7 approval.
Although one phase 3 trial showed that the drug, which helps decrease beta amyloid plaques in the brain, helped slow the progression of clinical dementia symptoms, another late-stage trial did not show the same benefit. Now, many doctors have expressed skepticism about its efficacy and whether or not it should be used, given the potential side effects.
Cost has also emerged as a major issue. After Biogen set the price at $56,000 per year, The Alzheimer’s Association, which has long been a staunch supporter of the drug and Biogen, called the cost “simply unacceptable.” For now, it is unclear to what extent Medicare will cover the drug.
