Alzheimer's drug discovery foundation's statement on FDA advisory committee's endorsement of donanemab

- The FDA Peripheral and Central Nervous System Drugs Advisory Committee unanimously voted that donanemab shows clinical benefit for the treatment of early Alzheimer's disease.

- If approved, donanemab would become the second disease-modifying drug for Alzheimer's to receive full approval, expanding the arsenal of available drugs needed to treat Alzheimer's with combination therapy.

Potential Impact of Donanemab Approval:

- Expansion of the first class of disease-modifying drugs, serving as the building blocks for future generations of drugs.

- Anti-amyloids offer opportunities for patients to modify the course of the disease while the field works towards developing more novel therapies.

Innovative Trials and Biomarker Tests:

- The donanemab trials demonstrate the field's ability to conduct innovative and rigorous biomarker-powered trials that provide a definitive answer on a drug's effectiveness.

- Biomarkers will continue to revolutionize clinical trial design as the field moves towards developing drugs that target novel pathways guided by the biology of aging.

Diversity in the Drug Pipeline:

- Nearly 75% of Alzheimer's drugs in development are exploring novel targets related to aging pathways like inflammation, metabolic disturbances, and vascular dysfunctions.

- Promising drugs from ADDF-funded companies are being developed, signaling a diverse pipeline.

Achievements of Alzheimer's Drug Discovery Foundation (ADDF):

- ADDF is dedicated to rapidly accelerating the discovery of drugs to prevent, treat, and cure Alzheimer's disease using a venture philanthropy model.

- Through the generosity of its donors, ADDF has awarded more than $290 million to fund over 750 Alzheimer's drug discovery programs, biomarker programs, and clinical trials in 20 countries.