Lecanemab

Despite approvals for Leqembi and Kisunla, attrition in Alzheimer’s and Parkinson’s pipelines persists, with Roche, Johnson & Johnson, Sage Therapeutics, and Otsuka discontinuing programs. Analysts attribute these decisions to clinical trial data and evolving commercial opportunities, noting the Alzheimer’s market is projected to be worth $15.5 billion by 2031, while Parkinson’s drugs are expected to reach $6.63 billion by 2029.

Kisunla (donanemab) approved by U.S. and U.K. for Alzheimer's, but U.K.'s NICE deems it not cost-effective. Kisunla clears beta amyloid and tau plaque, slowing cognitive decline in trials, but faces reimbursement challenges due to high cost and safety concerns.

Gail Youngdale, diagnosed with Alzheimer's, participates in a clinical trial for Leqembi, a drug that slows disease progression. Dr. Diana Kerwin, a renowned Alzheimer's researcher, expands her clinic to Oak Cliff, emphasizing accessibility. Leqembi, though not a cure, offers hope by potentially preventing the disease from reaching advanced stages. The Dallas Walk to End Alzheimer's is scheduled for Saturday morning.

Eisai submitted a BLA for lecanemab-irmb (Leqembi) subcutaneous autoinjector, aiming for weekly maintenance dosing. If approved, it would offer a 15-second administration method for patients with mild cognitive impairment or early-stage Alzheimer disease. The therapy is currently approved in several countries and under review in others, including the EU. The BLA is supported by phase 3 Clarity AD trial data, showing subcutaneous lecanemab produced greater amyloid plaque removal than IV administration.

Eisai and Biogen complete rolling submission to FDA for a subcutaneous maintenance dosing option of Leqembi, an Alzheimer's disease treatment. The BLA, granted Fast Track designation, builds on Clarity AD study data, aiming to enable weekly home or facility-administered SC doses. Results show Leqembi slows cognitive and functional decline by 27% over 18 months. Common adverse events include infusion reactions and amyloid-related imaging abnormalities. The SC formulation is designed to sustain effective drug levels post-plaque clearance, potentially improving convenience and reducing site visits.

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 to sustain clearance of amyloid-beta plaque, potentially more convenient than IV administration.

Eisai and Biogen complete US BLA for subcutaneous Leqembi, aiming to replace IV version with once-weekly autoinjector after initial IV course. This could differentiate Leqembi from Eli Lilly's Kisunla and boost uptake. Lilly is developing IV and subcutaneous forms of its follow-up drug remternetug. FDA has fast-track status for subcutaneous Leqembi but hasn't accepted the filing yet. Eisai and Biogen also filed for a monthly IV maintenance dose. Leqembi is approved in several countries but faces re-examination in the EU. Biogen reports $67 million in Q3 sales, with plans to expand subcutaneous use into induction phase by Q1 2026.

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 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.