Alliance Celebrates Second-Ever FDA Traditional Approval of Disease-Modifying Therapy for Alzheimer’s and Calls on Medicare to Stop Rationing Coverage

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. Known as Kisunla, the amyloid plaque-targeting therapy is part of the first wave of disease-modifying monoclonal antibody therapies for early Alzheimer’s. The FDA  requires that clinical benefit be shown before a traditional approval can be granted.

Alliance President and CEO Sue Peschin, MHS, issued the following statement in response to the FDA’s traditional approval of Kisunla:

“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 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.”

About the Alliance for Aging Research

Since 1986, the Alliance for Aging Research has served as a trusted source of health information for both consumers and health care professionals on diseases and conditions that disproportionately affect older adults and has led numerous successful advocacy campaigns promoting the health and independence of older adults. The Alliance is dedicated to changing the narrative to achieve healthy aging and equitable access to care. We strive for a culture that embraces healthy aging as a greater good and values science and investments to advance dignity, independence, and equity. Learn more about the Alliance at www.agingresearch.org.

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To schedule an interview with Sue Peschin, president and CEO of the Alliance for Aging Research, please contact Katie Riley, Vice President of Communications, Alliance for Aging Research, at [email protected] or (202) 688-1229, or John O’Connor at [email protected] or (202) 981-5042.