TFS Chemicals - Aspire
Pharma Focus America
Sino Biological - Cytokine

ADDF Releases Statement Regarding FDA's Traditional Approval of Lecanemab (Leqembi)

Friday, July 07, 2023

The Alzheimer's Drug Discovery Foundation (ADDF) is pleased to announce the FDA's approval of lecanemab (Leqembi), a monoclonal antibody, for the treatment of patients with mild cognitive impairment or early stage Alzheimer's disease who have confirmed amyloid plaques in the brain. This approval is a major milestone, as it is the first disease-modifying treatment for Alzheimer's to receive traditional approval, and it represents a conversion from accelerated to full traditional approval by the FDA.

Dr. Howard Fillit, Co-Founder and Chief Science Officer of ADDF, expressed optimism about this achievement, stating that the approval of Leqembi will have a positive impact on further advancements and investments in the Alzheimer's research pipeline. He emphasized the need to expand the focus and develop the next generation of drugs based on the biology of aging, which will enable a combination therapy and precision medicine approach.

The FDA has included a warning on the drug's label to alert patients and caregivers about potential risks associated with amyloid-related imaging abnormalities (ARIA).

This milestone underscores the importance of novel biomarkers and diagnostic tools in selecting the appropriate patients for anti-amyloid therapies and advancing the development of future drug classes. Biomarkers such as the Amyvid® PET scan, which received early funding from ADDF, are already being used in clinical trials to enroll patients and demonstrate target engagement for amyloid-targeting drugs like Leqembi. Combined with early and accurate diagnosis, these biomarkers allow clinicians to better understand the individual pathologies of patients and optimize treatment accordingly.

Dr. Fillit highlighted the crucial role of biomarkers in drug development, emphasizing that a precision prevention approach tailored to a patient's biomarker profile will eventually help slow down and potentially halt the progression of Alzheimer's disease.

While anti-amyloid drugs serve as an important starting point, the future of Alzheimer's treatment lies in combination therapy and precision medicine. The current Alzheimer's pipeline is diverse, with more than 75% of drugs exploring novel targets, including those related to misfolded proteins, inflammation, metabolic disturbances, vascular issues, and other factors associated with the disease's onset. Notably, ADDF-funded companies, such as Therini Bio and NeuroTherapia, are making promising advancements in researching novel pathways related to fibrin-driven inflammation and neuroinflammation, respectively.

Dr. Fillit acknowledged that the journey toward effective Alzheimer's treatments is ongoing and stressed the importance of pursuing accessible diagnostics, new prevention approaches, and treatments that target the various underlying causes of the disease. Building upon the momentum gained from Leqembi's approval, ADDF remains committed to advancing research efforts and bringing innovative therapies to market.

patheon - Mastering API production at every scaleWorld Vaccine Congress Europe 2024World Orphan Drug Congress 2024Future Labs Live USA 2024patheon - Revolutionizing PharmaHealthcare CNO SummitHealthcare CMO Summit