Alzheimer’s Association Statement on European Medicines Agency Negative Opinion on Kisunla® for the Treatment of Alzheimer’s Disease
“For far too long, people living with Alzheimer’s hoped for treatments — now they are available yet regulatory agencies such as the EMA continue to deny people living with a fatal disease access. It is wrong,” said Joanne Pike, DrPH, Alzheimer’s Association president and CEO.
This decision is out of step with the state of the science, and the decisions of other regulatory agencies. The Alzheimer’s Association calls on the EMA to reverse this decision and for the individual health agencies in these countries to reject today’s opinion and allow their citizens the opportunity to access treatment.
“As the EMA did when they first delayed approval for another treatment, Leqembi®, we expect the EMA will quickly reverse this decision,” continued Pike. “It is a shame that the EMA is delaying access to a treatment that benefits people in the earliest stages.”
While not a cure, this treatment can slow progression of the disease when taken in the early stages of Alzheimer’s, allowing people more time to participate in daily life and live independently. Kisunla was granted traditional approval by the U.S. Food and Drug Administration (FDA) in July 2024.
About the Alzheimer's Association
The Alzheimer’s Association is a worldwide voluntary health organization dedicated to Alzheimer’s care, support and research. Our mission is to lead the way to end Alzheimer's and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer's and all other dementia®. Visit alz.org or call 800.272.3900.