TAHO Pharma Takes a Bold Step with New Anticoagulant Film Submission to FDA

TAHO Pharma Submits NDA for Revolutionary Anticoagulant Film

In an exciting development for the pharmaceutical industry, TAHO Pharmaceuticals Ltd. has recently announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TAH3311, touted as the world’s first Apixaban Oral Dissolving Film (ODF). This breakthrough promises to transform anticoagulant therapy, especially for patients facing swallowing difficulties.

A Major Regulatory Milestone

The submission of the NDA signifies an important milestone for TAHO Pharma as they seek to bring innovative and accessible treatments to patients on a global scale. TAH3311 represents a substantial step forward in the delivery of Apixaban, a well-regarded anticoagulant. It's noteworthy that each year, over 15 million individuals worldwide suffer from strokes, with more than half of stroke survivors facing challenges with swallowing (dysphagia). This condition not only affects quality of life but also predisposes them to further health risks such as pneumonia, malnutrition, and dehydration.

The Innovative Delivery System

Developed using TAHO's proprietary Transepithelial Delivery System (TDS) platform, TAH3311 is designed as an easy-to-use oral dissolving film. This patient-friendly formulation is particularly advantageous for elderly patients, stroke survivors, and others who may struggle to swallow traditional tablets. By simplifying administration and eliminating the necessity for swallowing solid forms, TAH3311 also lowers the risk of choking and aspiration pneumonia, addressing a critical unmet need in anticoagulant therapy.

Dr. Lee, CEO of TAHO Pharmaceuticals, emphasized the significance of this submission, stating, "The NDA submission for TAH3311 reflects our unwavering commitment to addressing unmet patient needs through cutting-edge science. We are proud to offer a patient-centered solution that has the potential to redefine the standard of care in anticoagulant therapy." This vision aligns with TAHO's broader mission of enhancing patient experiences and improving therapeutic outcomes through innovative drug delivery solutions.

Aims for Global Collaboration

The recent NDA submission is not just a regulatory formality; it marks a strategic move towards U.S. market entry. Additionally, TAHO Pharma is actively pursuing global partnerships that could help expedite the product's time to market, ensuring that the benefits of TAH3311 reach patients as swiftly as possible.

Understanding Apixaban

For context, Apixaban, co-developed under the brand name Eliquis® by Bristol-Myers Squibb (BMS) and Pfizer, is classified as a direct factor Xa inhibitor. It has received approval for various thromboembolic disorders, including stroke prevention in non-valvular atrial fibrillation and thromboprophylaxis following hip or knee replacement surgeries. Given its notable safety profile, it stands as a leader in the category of novel oral anticoagulants (NOACs).

About TAHO Pharmaceuticals Ltd.

Founded in 2010, TAHO Pharmaceuticals is a dynamic small-to-medium enterprise (SME) that specializes in developing innovative oral and transdermal drug delivery systems. The company’s proprietary TDS platform facilitates efficient transdermal and transmucosal delivery of small-molecule drugs, presenting significant benefits over conventional methods such as enhanced bioavailability, reduced gastrointestinal side effects, and tailored release profiles.

With a commitment to advancing patient care and improving quality of life globally, TAHO Pharmaceuticals aims to set new standards in drug delivery technology.

In conclusion, the NDA submission for TAH3311 holds immense promise for transforming anticoagulant therapy, potentially alleviating the challenges faced by patients who struggle with traditional dosage forms. TAHO Pharmaceuticals continues to pave the way for innovative solutions in healthcare.