Tuesday, June 8, 2021
In Search of the Abracadabra for Alzheimer's Medicines
I used to follow (and regularly blog about) new drugs in the pipeline for Alzheimer's treatment. Then I realized that the drugs weren't making it to the market place. While attending medical programs about R & D, I learned that it was going to be tough to find any magic treatments, much less "cures."
To it was interesting to read this week that for the first time in some 18 years, the FDA has approved use of a new drug, with the marketing name Aduhelm and the generic name Aducanumab (kind of sounds like abracadabra, doesn't it?), manufactured by Biogen.
Aduhelm is described by the FDA as an "amyloid beta-directed antibody," which was approved under an "accelerated approval pathway," to give "patients suffering from a serious disease earlier access to drugs when there is an expectation of clinical benefit despite some uncertainty about the clinical benefit of the drug."
But there is a lot of sobering news accompanying this announcement:
First, the mechanism of delivery: monthly intravenous infusions, which means a clinical visit lasting at least an hour per infusion.
Second, Biogen's own predictions about cost: a "list price" predicted to average $56,000 per year per patient! Yikes.
Third, the critical response from a range of experts in relevant research, pharmacy and health fields about the approval process to date, indicating a history of interruptions in the clinical trials when preliminary results showed little to no evidence of clinical benefit.
Fourth: the need for assessment before the first infusion with an MRI, plus recommended follow up MRIs prior to the 7th and 12th infusions, to assess the potential for ARIA-H, which are amyloid-related abnormalities, also potentially associated with edema in the brain.
Here are some links (and I'll try to keep this list up-to-date as new info comes in):
Draft Evidence Report dated 5/5/2021 from the Institute for Clinical and Economic Review on "Aducanumab for Alzheimer's Disease: Effectiveness and Value."
Letter from American Geriatrics Society dated 6/2/2021 to FDA expressing concern about "premature" approval
STAT's commentary, dated June 7, 2021 on FAQs: What You Need to Know about the Alzheimer's Drug Aduhelm
New York Times, dated June 8, 2021: FDA Approves Alzheimer's Drug Despite Fierce Debate Over Whether it Works