TAHO Pharmaceuticals announced that on October 30 (Central European Time), it officially submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its new drug TAH3311. This is the world’s first orally dissolvable film formulation of Apixaban, marking the company’s formal entry into the European market and representing a significant step forward in the global anticoagulant sector.
Apixaban, jointly developed by BMS and Pfizer under the brand name Eliquis, is an oral anticoagulant primarily used to prevent stroke and thrombosis in patients with atrial fibrillation, making it one of the best-selling anticoagulants worldwide. Currently, only tablet formulations are available, which can pose difficulties for elderly patients or stroke patients with swallowing issues.
Statistics show that approximately 15 million stroke patients are diagnosed globally each year, with about half experiencing swallowing difficulties, and 13% developing long-term disabilities. These patients often need to crush tablets daily, which is inconvenient and can affect accurate dosing and treatment adherence.
TAH3311 utilizes TAHO’s proprietary Transepithelial Delivery System (TDS) for transoral mucosal absorption, allowing the drug to be rapidly absorbed through the oral mucosa. The film dissolves completely within minutes when placed on the tongue, requiring no water. This formulation not only enhances convenience and safety for patients but also helps improve adherence during long-term therapy, representing a major innovation in Apixaban formulation.
According to EU regulatory procedures, after document validation, the EMA will conduct a scientific assessment of approximately 210 days, followed by final approval by the European Commission within 67 days. TAHO noted that the TAH3311 submission represents a key advance for the company in Europe’s stroke prevention and anticoagulant markets, with plans to coordinate market strategies with local partners to accelerate product launch.
In recent years, TAHO Pharmaceuticals has focused on developing new drug formulations under the 505(b)(2) pathway, leveraging its TDS technology to improve existing drug formulations and the patient administration experience. Its product portfolio includes TAH4411, an orally dissolvable antiemetic film for chemotherapy patients already marketed in Japan; TAH9922, an ADHD oral solution licensed for development in the United States; and TAH3311, the orally dissolvable anticoagulant film for which the U.S. New Drug Application (NDA) has been completed. Additionally, the company is advancing new formulations including an opioid antidote, pediatric ADHD patches, and orally dissolvable films for opioid addiction treatment, gradually establishing a globally diversified licensing and collaborative development pipeline.
Resource: 泰合TAH3311正式申請歐洲藥證 全球首款Apixaban口溶膜拚攻抗凝血市場
