Over 40 Organizations Share Information with FDA on Unmet Clinical Need for Alzheimer’s Disease-related Psychosis
Published June 7, 2022
On Friday, June 3rd, the Alliance for Aging Research and over 40 additional organizations submitted a comment letter to the FDA highlighting the challenges that patients with Alzheimer’s disease-related psychosis (ADP) face in accessing effective treatments for unwanted hallucinations and delusions.
The letter was sent to the members of the Psychopharmacologic Drugs Advisory Committee, who will meet on June 17th, 2022, to evaluate whether the agency should extend the list of on-label treatment indications for the drug pimavanserin to include ADP. Pimavanserin was previously approved by the FDA for the treatment of Parkinson’s disease-related psychosis.
In the letter, the organizations do not take a position on whether the FDA should approve the use of pimavanserin for the treatment of ADP. The Alliance defers to the FDA’s regulatory expertise and judgment in determining the safety and effectiveness of therapeutics, as supported by available clinical data. However, the letter provides the committee with important information on the challenges that patients that experience ADP – including hallucinations and delusions – and their caregivers face daily. The letter provides detail on the following:
- Data on prevalence and how symptoms are experienced by individuals with ADP
- Barriers to appropriate clinical treatment of ADP, including:
- the current absence of FDA-approved on-label treatments for ADP
- Quality measures that limit access to clinically appropriate treatment, and
- Efficacy and safety information on currently treatment regimens.
About the Alliance for Aging Research
The Alliance for Aging Research is the leading nonprofit organization dedicated to accelerating the pace of scientific discoveries and their application to vastly improve the universal human experience of aging and health. The Alliance believes advances in research help people live longer, happier, more productive lives and reduce healthcare costs over the long term. For more than 30 years, the Alliance has guided efforts to substantially increase funding and focus for aging at the National Institutes of Health and Food and Drug Administration; built influential coalitions to guide groundbreaking regulatory improvements for age-related diseases; and created award-winning, high-impact educational materials to improve the health and well-being of older adults and their family caregivers. For more information, visit www.agingresearch.org.
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