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Alliance and Partners Urge FDA Advisory Committee to Listen to Perspectives of Alzheimer’s Patients and Families when Considering Expansion of Brexpiprazole Label

Published April 14, 2023

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The Alliance for Aging Research remains steadfast in advocating for Alzheimer’s patients, their care partners, families, and long term care and health providers including advocacy for treatments that address symptoms. On April 3, the Alliance and the American Society of Consultant Pharmacists (ASCP) shared a letter with the U.S. Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee and on April 13 the Alliance and ASCP joined by 31 partners submitted a sign-on letter to the docket for the April 14 Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee.

Alliance President & CEO Sue Peschin, MHS, delivered the following public comment at the FA’s joint advisory committee meeting on April 14:

Hi everyone. I’m Sue Peschin, and I serve as president and CEO of the Alliance for Aging Research. The Alliance receives funding from the sponsor for non-branded health education and advocacy on neuropsychiatric symptoms of dementia.

Last night, the Alliance and the American Society for Consultant Pharmacists submitted a sign-on letter to docket asking all of you to consider the perspectives of people living with Alzheimer’s disease, family and other care partners, long-term care and health care providers, and advocates as you discuss a proposed expansion of the brexpiprazole label for agitation associated with Alzheimer’s disease—or AAD. We were joined by 31 partners, including the American Association of Post-Acute Care Nursing, Caregiver Action Network, National Hispanic Medical Association, National Minority Quality Forum, The Association of Frontotemporal Degeneration, UsAgainstAlzheimer’s, and Voices of Alzheimer’s.

It goes without saying, but I’m going to say it anyway—Alzheimer’s, by itself, is a progressive and fatal disease. As you discuss the risks and benefits of brexpiprazole for AAD, please recognize this—neuropsychiatric symptoms of Alzheimer’s, such as agitation, not only worsen Alzheimer’s-related cognitive and functional decline, but also accelerate time to institutionalization and eventual death. A large longitudinal observational study published in the September 2013 issue of the American Journal of Psychiatry showed that it is the symptoms—not the use of antipsychotic medications—that predict nursing home admission and death.

One year ago, CMS announced that it would refuse to cover an entire class of FDA-approved disease-modifying therapies for the treatment of MCI and early dementia due to Alzheimer’s disease, which effectively cut off access for beneficiaries living with early Alzheimer’s, except wealthy seniors who could pay out-of-pocket. It’s a direct and disheartening illustration of what happens when bureaucrats crunch numbers and forget about the people behind the math.

Currently there is no FDA-approved medication for the on-label treatment of agitation associated with Alzheimer’s disease. The published 2023 analysis of the safety, efficacy, and tolerability of brexpiprazole for Alzheimer’s found statistically significant greater improvements in agitation versus placebo, supporting the findings of two prior clinical trials. This sNDA follows eight years of accumulated safety and efficacy data on the original NDA. We were thrilled to see the FDA’s comprehensive review of the clinical trial data, and we have full confidence in their recommendation to expand the label for brexpiprazole to AAD.  

When I hear someone speak about agitation as only needing to be managed with behavioral techniques, I wonder—has that person ever seen someone they care about repeatedly unable to stop restlessly rocking or pacing, screaming, or hitting themselves uncontrollably? If not, I would ask them to think about what that might be like for the person experiencing it—and for the caregiver trying their best to help.

The reality is that these symptoms often require medical attention, for the safety of both the patient and the caregiver. Providers are professionally trained to a start with non-pharmacologic approaches, such as redirection or exercise. However, if these approaches are ineffective and ongoing symptoms progress to physically aggressive behavior towards self or others, providers may need to recommend medication.

And that is truly the crux of benefit-risk. Individuals living with Alzheimer’s meet with their health care providers, often alongside family caregivers, to discuss the benefits and risks of whether to take a drug or not. Severe agitation diminishes quality of life and hastens death in people with Alzheimer’s. Preserving a patient’s dignity should be of the utmost importance. Please consider the perspectives of patients, families, and providers as you make your important decisions today. Thank you.

For more information, see Project PAUSE.

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