EISAI CO

Roche may seek accelerated U.S. approval for trontinemab, its Alzheimer’s drug, if it continues to show significant amyloid reduction. Trontinemab, designed to easily pass the blood-brain barrier, demonstrated quicker amyloid clearance than Kisunla in Phase 2 testing. Roche plans to expand the trial to 120 volunteers, with preliminary safety data showing lower ARIA rates than other drugs.

Eisai and Biogen announce completion of BLA submission to FDA for lecanemab-irmb (LEQEMBI) subcutaneous autoinjector for weekly maintenance dosing in early Alzheimer's disease, granted Fast Track designation. LEQEMBI targets highly toxic protofibrils, potentially preventing neuronal injury and cognitive decline.

Eisai and Biogen complete US rolling BLA for subcutaneous Leqembi, aiming to replace IV version with once-weekly autoinjector, potentially differentiating from Eli Lilly's Kisunla and speeding up drug uptake. Lilly focuses on IV and subcutaneous forms of remternetug. FDA fast-track status for subcutaneous Leqembi but has not accepted filing yet. Eisai and Biogen also file for monthly IV maintenance dosing. Leqembi approved in US, Japan, China, South Korea, Hong Kong, Israel, UAE, and GB, but EU and Australia decisions against approval. Biogen reports $67 million in Q3 sales, with plans to expand subcutaneous injector use into induction phase by Q1 2026.

The 'golden age' of medicine sees breakthroughs in mRNA, ADCs, and microbiome therapies, with Casgevy's approval marking a CRISPR milestone. Oncology and immunology dominate drug sales, while obesity, Alzheimer’s, and CVD treatments gain momentum. Precision medicine and cost optimization are priorities, leveraging AI, blockchain, and IoMT. Health system reforms in the U.S. and EU introduce stricter pricing regulations, challenging drug manufacturers.

Eisai and Biogen announce completion of BLA submission to FDA for lecanemab-irmb (LEQEMBI) autoinjector for Alzheimer's disease treatment, with a potential PDUFA action date. LEQEMBI, indicated for early AD, aims to maintain effective drug concentrations and reduce protofibril-induced neuronal injury, offering a more convenient subcutaneous administration method.

Eisai completes rolling BLA submission to FDA for Leqembi subcutaneous autoinjector for weekly maintenance dosing in Alzheimer's disease patients.