Health
Anti-MTBR (microtubule binding region) Tau Antibody Etalanetug Granted FDA Fast Track Designation
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that etalanetug (development code: E2814), an investigational anti-MTBR (microtubule binding region) tau antibody, was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). Fast Track designation is an FDA program that is intended to facilitate and expedite development of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition, such as Alzheimer's
About this update from Eisai Co., Ltd.
[{"type":"text","content":"TOKYO, Sept. 16, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that etalanetug (development code: E2814), an investigational anti-MTBR (microtubule binding region) tau antibody, was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). Fast Track designation is an FDA program that is intended to facilitate and expedite development of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition, such as Alzheimer's disease (AD), and provide opportunities for frequent interactions with the FDA.","length":631,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/Eisai Inc.)","displaySize":"","headline":null,"caption":"(PRNewsfoto/Eisai Inc.)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":270,"url":"https://media.zenfs.com/en/prnewswire.com/700c877d19b6c71682541aaa54eb34cb"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/9Joz3h2FdUIAcnZzvGHF3Q--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTQ3NjtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/700c877d19b6c71682541aaa54eb34cb","width":400,"height":270}},"href":"https://mma.prnewswire.com/media/2704698/Eisai_Inc_Logo_New.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"AD is a chronic, progressive, neurodegenerative disease characterized by formation of protein deposits known as plaques made of amyloid-beta aggregates and neurofibrillary tangles made of tau protein in the brains of people living with AD. The data show that amyloid-beta protofibrils and tau tangles play roles in the neurodegeneration process.1,2,3","length":350,"tagName":"p"},{"type":"text","content":"Etalanetug is an anti-tau antibody that targets specific tau species containing MTBR, tau seeds that spread tau pathology to different brain regions. Etalanetug was discovered as part of the research collaboration between Eisai and University College London.","length":258,"tagName":"p"},{"type":"text","content":"In the Phase I/II clinical trial (Study 103, NCT04971733) targeting patients with Dominantly Inherited Alzheimer's Disease (DIAD), target engagement with MTBR-tau species in cerebrospinal fluid (CSF) with etalanetug was confirmed. Additionally, there was a reduction in CSF MTBR-tau243, a biomarker reflecting brain tau pathophys...