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TOKYO - Eisai Co., Ltd. (Market cap: $10 billion), a InvestingPro-rated prominent player in the pharmaceuticals industry with a robust 78.6% gross profit margin, announced Tuesday that its investigational anti-MTBR tau antibody etalanetug has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of Alzheimer’s disease. According to InvestingPro analysis, the company’s stock currently trades below its Fair Value.
The FDA’s Fast Track program aims to expedite development and review of drugs addressing serious conditions with unmet medical needs. The designation provides Eisai with opportunities for more frequent FDA interactions during the development process.
Etalanetug targets specific tau species containing microtubule binding region (MTBR), which are believed to spread tau pathology across different brain regions in Alzheimer’s disease patients. The drug was discovered through research collaboration between Eisai and University College London.
In a Phase I/II clinical trial involving patients with Dominantly Inherited Alzheimer’s Disease (DIAD), etalanetug demonstrated target engagement with MTBR-tau species in cerebrospinal fluid. The company reported a reduction in CSF MTBR-tau243, a biomarker reflecting brain tau pathophysiology, and observed a trend toward decreased tau PET signal.
The antibody is currently being evaluated in two clinical trials: a Phase II/III study for DIAD led by Washington University School of Medicine, and a Phase II trial targeting sporadic early Alzheimer’s disease. Both studies are examining etalanetug in combination with lecanemab, an anti-amyloid β protofibril antibody.
Alzheimer’s disease is characterized by the formation of amyloid-beta plaques and neurofibrillary tangles composed of tau protein in the brain. While recent treatment advances have focused on amyloid beta, targeting tau represents another potential approach to addressing the disease’s progression.
The information in this article is based on a press release statement from Eisai. InvestingPro subscribers have access to 8 additional exclusive tips about Eisai’s financial performance and market position, along with comprehensive financial health metrics that show the company maintains a GOOD overall financial health score.
In other recent news, Eisai Co. reported significant growth in sales of its Alzheimer’s drug, Leqembi, with a 269% year-over-year increase, reaching ¥23.1 billion in the first quarter. This surge in sales included a notable ¥5.3 billion from one-off demand in China, as previously noted by its partner Biogen. When adjusted for this special demand, underlying sales still showed a robust 84% growth, amounting to ¥17.8 billion. Additionally, Eisai and Biogen have initiated a rolling submission to the U.S. Food and Drug Administration for LEQEMBI IQLIK, a subcutaneous autoinjector version of lecanemab-irmb. If approved, this would be the first anti-amyloid treatment available for at-home administration from the start of treatment for early Alzheimer’s disease. The companies also presented data demonstrating that their investigational subcutaneous autoinjector for lecanemab-irmb offers similar efficacy and safety compared to the intravenous formulation. This data was shared at the Alzheimer’s Association International Conference in Toronto, highlighting the potential for home-based maintenance treatment. These developments mark significant advancements in Eisai’s Alzheimer’s treatment offerings.
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