FDA instituted its Accelerated Approval Program for Biogen’s Aduhelm (aducanumab)
This week, the FDA approved Aduhelm (aducanumab), “the first novel therapy approved for Alzheimer’s disease since 2003.” Columbus Memory Center is proud to have played an important role in aducanumab’s journey to FDA approval and will continue research for this and many other drugs that will aid in our fight to end Alzheimer’s disease.
“This is a major moment in medical history. It is a moment I have been working towards for 30 years. We finally have a drug available for Alzheimer’s disease that modifies and slows the illness. A bright new day has dawned for people in the earliest stages of this illness. We will continue to work tirelessly to change Alzheimer’s disease into a mere nuisance.” – Dr Liss.
How does this drug, Aduhelm, work?
This groundbreaking new drug, for patients with earlier stages of Alzheimer’s, slows cognitive decline by removing the amyloid beta proteins that block neurotransmitters. Aduhelm will be a monthly infusion.
When will it become available?
“The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need.” Biogen has been working around the clock in preparation of the announcement, but it still may take several weeks to be available. The precise guidelines for use of this medication have not been released.
Who will benefit from this drug?
This drug has only been researched in patients with very mild, early-stage Alzheimer’s and Dementia. Biogen will set specific criteria a patient must meet to be eligible for this new drug. Once the criteria have been announced, we will begin to contact those who will be eligible.
How do I find out if I am eligible?
You must be evaluated by a neurologist in a clinical setting before you can be considered for this treatment. To be evaluated by Dr. Liss, you must see your primary care physician and be referred with a diagnosis. Recurring patients of Dr. Liss will be notified if they meet eligibility.
How much will this cost?
Due to the nature of the medication, it will be costly. However, at this time, cost and coverage have not been determined through Medicare and other insurers. Medicare and insurers are working diligently to keep costs for patients as low as possible.
What if I am not eligible?
Not all patients will be eligible for Aduhelm. Those who are not eligible can inquire about research studies with promising new medications like Aduhelm. Aduhelm is a not just a new treatment it is a foundation in which more research and new therapies can be built. Columbus Memory Center is excited to see what the future of Alzheimer’s Research brings.
Visit our Research Opportunities page for more information on other Research Studies.