Alzheimer's Association Statement on European Medicines Agency Negative Opinion on Leqembi for the Treatment of Alzheimer's Disease

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Jul 26, 2024, 12:46 ET

CHICAGO, July 26, 2024 /PRNewswire/ -- The Alzheimer's Association is disappointed by today's decision by the European Medicines Agency (EMA) to recommend against allowing Leqembi^® to be marketed across the European Union.

"The EMA has denied people living with Alzheimer's and their families more time," 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 the U.S., Chinese, South Korean, Israeli, Hong Kong and Japanese regulatory agencies."

The Alzheimer's Association hopes individual health agencies in these countries will reject today's opinion and allow their citizens the opportunity to access treatment for this devastating, fatal disease.

"It is wrong. People living with Alzheimer's in some parts of the world are able to benefit from scientific advancements, while others are denied the opportunity. This decision by the EMA will deepen an already emerging global health inequity in Alzheimer's disease," Pike said.

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. Leqembi was granted traditional approval by the U.S. Food and Drug Administration (FDA) in July 2023.

Alzheimer's Association^®The Alzheimer's Association leads 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 the 24/7 Helpline at 800.272.3900.

SOURCE Alzheimer's Association