ADDF STATEMENT ON FDA DECISION TO HOLD ADVISORY COMMITTEE FOR DONANEMAB

NEW YORK – March 8^th, 2024 – Drugmaker Eli Lilly & Company today announced the FDA expects to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to further review and discuss donanemab’s efficacy and safety profile before making its final decision on whether to grant the drug approval. The advisory committee is scheduled to take place later this year.

“Today’s FDA decision is not a setback, but another step forward in the drug approval process, with the regulatory agency doing its due diligence before making its decision to approve the drug for patients,” says Howard Fillit, MD, Co-Founder and Chief Science Officer of the Alzheimer’s Drug Discovery Foundation (ADDF). “The decision to hold an advisory committee before granting approval follows the regulatory process that was used for the other drugs in this class, including Leqembi.”

This news does not take away from the breakthroughs the first class of disease modifying treatments have brought to the Alzheimer’s landscape, which have proven the field’s ability to conduct and design rigorous clinical trials.

“The TRAILBLAZER-ALZ 2 trial is emblematic of a new era of Alzheimer’s research where we are now able to conduct innovative trials that can definitively tell us whether a drug is effective. As the first class of Alzheimer’s drugs come to market—with the promise of more novel therapies to follow—the field is working together to build the path forward for future drug approvals.” 

The donanemab trial used a “goldilocks strategy” to identify patients who were in the early stages of Alzheimer’s and most likely to benefit from treatment. A unique aspect of this trial was the use of both the Amyvid® and Tauvid™ PET scans to enroll patients with confirmed amyloid plaques, allowing investigators to confirm clearance or reduction of the pathology in later scans. Lilly’s innovative biomarker-powered trial exemplifies the importance of developing biomarkers and drugs in tandem to support drug development, trial enrollment, and target engagement. 

Based on the broader biology of aging framework, anti-amyloid therapies will serve as the first line of defense in the arsenal of drugs needed to treat Alzheimer’s. Currently, nearly 75% of Alzheimer’s drugs in development are exploring novel targets related to the various aging pathways like inflammation, metabolic disturbances, and vascular dysfunction. The ultimate goal is to combine amyloid-clearing drugs with novel therapies in a precision medicine approach based on each patient’s individual biomarker profile—like within cancer care. Early detection and intervention will be further supported by more accessible and scalable blood-based biomarkers like ALZpath’s pTau 217 assay and C2N Diagnostic’s Precivity AD test, both of which received ADDF funding.  

Today’s news follows the FDA approval of anti-amyloid Leqembi last July, the first-ever disease modifying therapy for Alzheimer’s to receive traditional approval.

“Anti-amyloids are only one part of the solution. There remains a pressing need to develop the next generation of drugs and biomarkers targeting the various aging pathways that can be administered via a combination therapy and precision medicine approach,” notes Dr. Fillit. “It is crucial we build on recent momentum to move towards a future where we can halt the progression of Alzheimer’s or prevent it altogether by addressing the complexity of the disease with an arsenal of novel drugs guided by the biology of aging.”