On June 7, 2021, the FDA announced their approval of Aduhelm (aducanumab) as a novel treatment for Alzheimer's disease. The National Institute on Aging (NIA) released a statement praising the "milestone achievement", which comes after a nearly 20 years gap in progress.
Doctors and researchers consider this as not an end point or "cure", but rather an important step forward in ongoing studies of the disease. The NIA further emphasized their commitment "to press forward with its robust and diverse research portfolio in the area of therapy development, building on the advancements we have achieved thus far."
Patients and their families are excited to learn if this new therapy may benefit them personally, but many questions still surround this development.
Here are the answers we have so far:
1. Who is the drug for?
According a CNN interview with Dr. Rany Aburashed, chief of neurology at Memorial Healthcare, while the new drug received a broad approval for use in clinical diagnoses of Alzheimer's disease, it may only be beneficial to a specific subset of patients. Individuals will need to work with their own doctors to determine if this treatment would be beneficial in their own particular case, taking into account risks and other contraindications.
It is noteworthy that trials and development of this drug targeted mild cases of the disease as opposed to progressive ones.
2. How does it work?
Aduhelm (aducanumab) is an infusion therapy that uses a lab-made antibody to target plaque build-up in the brain. Amyloid plaque is associated with Alzheimer's disease and dementia.
3. Why is there controversy?
Like many drugs, this treatment comes with a hefty price tag. At over $50,000 for a one-year supply, Medicare patients could find themselves with copay responsibilities of more than $10,000.
Additionally, there are some experts who are skeptical about whether or not the drug actually works - or if the benefit of using the drug outweighs some of the significant risks of adverse reactions.
While the debate may continue in regulatory and scientific circles, families who have been affected by the disease may find hope in the renewed attention and interest surrounding the development of new therapies and treatments.