Once-weekly subcutaneous injections of Eisai Co., Ltd./Biogen, Inc.’s Leqembi (lecanemab) provided 14% greater amyloid plaque clearance at six months in patients with early Alzheimer’s disease than the US Food and Drug Administration-approved I.V. version of the amyloid protofibril-targeting antibody administered every two weeks. Eisai will submit 12-month results in a biologics license application (BLA) seeking FDA approval for the subcutaneous version by the end of March 2024.
CTAD 2023: Subcutaneous Leqembi Bests I.V., Could Open Access
At-Home Option An Important Growth Driver for Eisai/Biogen
The first results for subcutaneous lecanemab in early Alzheimer’s disease show better amyloid clearance with slightly higher ARIA rates than the I.V. version. Eisai also presented Phase III Clarity AD updates and initial long-term extension data.
More from Clinical Trials
• By
Strong sales growth for the German group’s SGLT2 inhibitor in 2024
• By
After a more than three-year hiatus, China's Hengrui has signalled its return to multiregional Phase III trials as it looks to globalize its innovative pipeline. Meanwhile, a number of other Chinese players have announced plans to kick off Phase III trials this year and beyond.
• By
After failing a Phase II monotherapy study in early Parkinson’s, Cerevance will focus on adjunctive therapy without abandoning the monotherapy concept.
• By
The firm has lofty ambitions for the aldosterone synthase inhibitor to treat hypertension and kidney disease.
More from R&D
• By
The ZENITH study is a landmark for Merck’s first-in-class activin signalling inhibitor and pulmonary arterial hypertension treatment.
• By
Seeking cell therapy approaches to cure type 1 diabetes, Vertex abandons a candidate encapsulated to avoid immune system detection but hopes to file another candidate for approval in 2026.
• By
A Phase III trial testing the cortisol modulator showed a benefit on PFS and OS in patients with platinum-resistant ovarian cancer.