TAHO Pharma submits FDA application for world's first Apixaban Oral Dissolving Film

Recently, TAHO Pharma announced that it has submitted a New Drug Application (NDA) to the U.S. FDA for TAH3311, the world's first Apixaban Oral Dissolving Film (ODF).

Apixaban (marketed under the brand name Eliquis®), originally co-developed by Bristol-Myers Squibb (BMS) and Pfizer, is an oral, selective, direct Factor Xa inhibitor. It is primarily indicated for reducing the risk of stroke and systemic embolism.

Apixaban was first approved in Europe in 2011, gained approval in the United States in 2012, and entered the Chinese market in 2013. Since its launch, the drug has maintained a consistent growth trajectory, with global sales reaching $20.699 billion in 2024, making it the highest-selling anticoagulant product worldwide.

TAH3311 is an innovative formulation designed to improve the delivery of apixaban, a widely used anticoagulant. According to the National Institutes of Health (NIH), stroke affects more than 15 million people worldwide each year, and over 50% of stroke survivors experience dysphagia. This condition places them at heightened risk for pneumonia, malnutrition, dehydration, and reduced quality of life.

Developed using TAHO's proprietary Transepithelial Delivery System (TDS) platform, TAH3311 is formulated as an easy-to-use Oral Dissolving Film (ODF). This patient-friendly format is particularly beneficial for stroke survivors, elderly patients, and others with swallowing difficulties, offering both greater convenience and improved treatment adherence. By eliminating the need to swallow solid dosage forms, TAH3311 helps reduce the risk of choking and aspiration pneumonia, addressing a critical unmet need in anticoagulant therapy.

About TAHO Pharmaceuticals Ltd

Founded in 2010, TAHO Pharma is a global small-to-medium enterprise (SME) specializing in innovative oral and transdermal drug delivery systems. Through its proprietary Transepithelial Delivery System (TDS) platform, TAHO enables efficient transdermal and transmucosal delivery of small-molecule drugs. The TDS platform provides significant advantages over conventional delivery routes, including tailored release profiles (from rapid onset to sustained delivery), reduced gastrointestinal side effects, enhanced bioavailability, and simplified administration for patients with compliance challenges. With TAHO's scientifically differentiated technology and clinically meaningful solutions, TAHO is dedicated to advancing patient care and improving quality of life worldwide.