Today, the U.S. Food and Drug Administration (FDA) granted the second-ever traditional approval to a disease-modifying therapy for the treatment of early, symptomatic Alzheimer’s disease: https://lnkd.in/etZV6DHy. Known as Kisunla, the amyloid plaque-targeting therapy is part of the first wave of disease-modifying monoclonal antibody therapies for early #Alzheimers. The FDA requires that clinical benefit be shown before a traditional approval can be granted. On behalf of the Alliance for Aging Research, I issued the following statement in response: https://lnkd.in/esRwZ7sT “It is a blessing for people living with early Alzheimer’s to have a second, FDA-approved treatment option available. The community understands that Kisunla is not curative but has shown promise in clinical trials in delaying the progression of the disease. This is of key importance to people living with early Alzheimer’s, where quality-of-life outcomes–such as overall cognition, personality, and the ability to care for oneself–are the ones that matter most. When it comes to evaluation of risk/benefit for people living with early Alzheimer’s, the FDA’s senior career staff have acted with integrity, and carefully guarded their independence in a highly politicized environment. The number of adverse events related to Kisunla are low, and especially when compared to almost any oncology drug. Yet, because Alzheimer’s is a deadly disease primarily affecting older adults, clinical paternalism is common. For example, we’ve heard senior officials in the Medicare program recklessly refer to people living with early Alzheimer’s as ‘relatively healthy.’ We wonder—would they say the same about someone living with a small malignant tumor? There is only one other FDA-approved first-line therapeutic in this class currently available—Leqembi—but its availability is highly rationed in #Medicare (by the Centers for Medicare & Medicaid Services) and in the private payer market. We encourage Medicare officials and private payers to recognize that people living with early Alzheimer’s and their families are more than capable of assessing risk/benefit with their clinicians, and to mutually decide the right treatment decision for them. Medicare has covered #FDA-approved medicines for every other condition, from arthritis to cancer to HIV. Now, both Kisunla and Leqembi have met the FDA’s standard of review for traditional approval and clinical benefit for both treatments were validated by unanimous votes of the FDA’s Advisory Committee of external experts. Medicare must immediately stop rationing care to people living with early Alzheimer’s and provide class-wide access to both Leqembi and Kisunla the same way they do for FDA-approved medications for all other diseases.” #AccessNow
The parallels between Alzheimer’s Disease and cancer are staggering (plaques vs tumors, cost of treatments, devastating effects on patients and families, to name just few.). And yet the discourse is completely different. We don’t think twice about the need for a biopsy for cancer and yet CSF testing is too invasive for these “otherwise healthy patients”. Thank you for calling this out. It is time to put politics aside and focus on an informed dialogue of risk vs. benefit. These drugs aren’t perfect but they can make a difference for the right person. Dr. Sharon Cohen once shared how she watches her patients lose themselves slice by slice. It is our brains that make us who we are. It is well-past the time to end the apathy and complacency!
No drug is safe to take that claims to slow down or offer a possible cure for dementia. There are many nutritional supplements and herbs that will slow down the condition and greatly improve the quality of life for someone living with dementia. For more information, please reach out to https://www.icacares.com/contact
donanemab-azbt too evil to even write? it is really weird for me to read a post about an FDA approval and no drug name. the brand name is cute, but what is the reason for withholding the reality of weird, convoluted, real but strange name of this drug? your statement does not say it either. i do not know what sort of weird PR branding stunt you are trying to play, but if you cannot write the name of this drug no one will trust you, certainly not me unless you just think we are too dumb. feel free to say it too, either we are too scared or too dumb of this big made up word it is another ambiguous monoclonal antibody of uncertain significance, almost literally MGUS for anyone who knows immunology, like hundreds (thousands?) of others. probably it will do little more than kill a few people and generate astronomical profit, we will see https://en.wikipedia.org/wiki/Three_wise_monkeys
Thanks Sue for all of your work and passion on this issue (both personally and professionally!) love this posting!!!!
Great news for patients!!! Exciting
Anthony Shop
2w
Amazing news for those of us whose families have been affected by Alzheimer’s! Keep up the great work!
This is great news as the early the diagnose is made, the more time a person has to maintain control.
Ray Bullman
2w
Sue, the tireless efforts by you and your staff are greatly appreciated.
Assistant Research Professor, University of Connecticut
1wThe dance depicted in the video is a bit incongruent with the fact that the drug showed a difference from placebo of 0.7 on a 0-18 cognition scale. Statistical significance doesn’t always equate clinical significance. Most people taking the medication may not notice a significant difference in their day to day life. Giving false hope is a concern.