Lecanemab

DelveInsight's report on Alzheimer's Disease pipeline highlights 110+ companies developing 120+ therapies, including key players like Neurodon, Sangamo Therapeutics, and Eisai Co Ltd. Notable therapies in clinical trials are NRDN-201, ST-501, and Simufilam. Recent developments include FDA approval of Leqembi and ongoing Phase 1 trials for ML-007/PAC by MapLight Therapeutics. The report covers pre-clinical to marketed phases, detailing drug MOA, ROA, and market dynamics.

Bioarctic's partner Eisai announces Mexican Medicines Agency approval of Leqembi (lecanemab) for early Alzheimer's treatment, following US, Japan, China, South Korea, Hong Kong, Israel, UAE, and UK approvals. The European Medicines Agency's CHMP also issued a positive recommendation.

Eisai and Biogen announce COFEPRIS approval of LEQEMBI® (lecanemab) for early Alzheimer’s disease, targeting soluble and insoluble Aβ aggregates. LEQEMBI is the first treatment shown to reduce disease progression and cognitive decline, already approved in the U.S., Japan, China, South Korea, Hong Kong, Israel, the UAE, and Great Britain. The approval is based on the Phase 3 Clarity AD study, which met primary and secondary endpoints with significant results.

Eisai announced COFEPRIS approval of Leqembi (lecanemab) for early Alzheimer's disease in Mexico. Leqembi, developed by BioArctic and Eisai, targets amyloid-beta aggregates, reducing disease progression. It's also approved in the U.S., Japan, China, South Korea, Hong Kong, Israel, UAE, and Great Britain.

BioArctic's partner Eisai announces COFEPRIS approval of Leqembi for early Alzheimer's disease in Mexico. Leqembi reduces Aβ protofibrils and plaques, slowing cognitive decline. It's also approved in the U.S., Japan, China, South Korea, Hong Kong, Israel, UAE, and Great Britain. Based on Phase 3 Clarity AD trial data, Leqembi met primary and secondary endpoints. Collaboration with BioArctic began in 2005, with Eisai leading clinical development and commercialization.

The EMA recommended lecanemab for early Alzheimer’s, focusing on patients less likely to experience ARIA side effects. If approved, it would be the first disease-modifying therapy in the EU. The drug showed modest cognitive decline slowing in early AD patients with one or no ApoE4 gene copy. Safety measures include MRI scans and a controlled access program. The UK’s NICE questioned the drug’s cost-effectiveness, while the Alzheimer Society of Ireland highlighted the need for broader support services.

Precision medicine uses biomarkers like blood tests and brain scans to improve Alzheimer’s diagnosis and treatment, potentially delaying onset by up to 20 years. Dr. Howard Fillit discusses the role of biomarkers, monoclonal antibody drugs, and lifestyle management in Alzheimer’s care, emphasizing the need for combination therapy and precision medicine to address the disease comprehensively.