ADDF Statement On FDA Advisory Committee’s Endorsement Of Lecanemab (Leqembi)

The FDA Advisory Committee’s endorsement of Leqembi ushers in a new era for Alzheimer’s therapeutics

Anti-amyloids are not the panacea, underscoring the need to develop novel drugs that can be used in combination therapy approaches

June 9, 2023—Today, the FDA Peripheral and Central Nervous System Drugs Advisory Committee unanimously voted that lecanemab (leqembi) showed clinical benefit in early Alzheimer’s disease, paving the way for a traditional approval of the drug. This milestone comes just ahead of its July 6th PDUFA date and if approved, Leqembi will be the first-ever disease-modifying treatment for Alzheimer’s to receive full approval.

“We are encouraged by the FDA Advisory Committee’s decision to endorse Leqembi, but we recognize that the mission to develop effective treatments for all patients with Alzheimer’s disease is far from over,” says Dr. Howard Fillit, Co-Founder and Chief Science Officer of the Alzheimer’s Drug Discovery Foundation (ADDF). “While this is an exciting step forward, our understanding of the biology of aging tells us we will need multiple therapies that target novel pathways and can be used in combination with other drugs, like anti-amyloids, for a precision medicine approach.”

As more new therapies move from discovery to development, there is an increased need to develop and utilize complimentary biomarkers and diagnostic tools that can identify the populations that will most benefit from various treatments. One of the biomarkers that formed the basis for the accelerated approval of Leqembi is the Amyvid® PET scan, which received early seed funding from the ADDF, and has helped to enroll patients and monitor progress in several monumental clinical trials. 

“Biomarkers offer the ability to match the right drugs to the right patients at the right time,” says Dr. Fillit. “As with other diseases of chronic aging, a precision prevention approach that begins with an early, accurate diagnosis and tailors drug combinations based on a patient’s individual biomarker profile will give us the best chance of slowing—and potentially stopping—disease progression.”

This milestone also underscores the recent progress made in the Alzheimer’s robust drug pipeline, demonstrating the field’s ability to run rigorous clinical trials that provide definitive answers on the effectiveness of new treatments with the support of biomarker monitoring. 

“In today’s pipeline, over three quarters of drugs in clinical development are targeting novel pathways, priming the field for the next generation of drugs that target a whole host of underlying factors,” adds Dr. Fillit.