On the 1st, EASYWELL BIOMEDICALS announced that its U.S. subsidiary, Tulex Pharmaceuticals, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TLX-041, a 505(b)(2) liquid oral formulation developed in collaboration with its partner for the treatment of diabetes insipidus. The drug is positioned to tap into an international market opportunity exceeding NT$2.1 billion.

According to EASYWELL, TLX-041 is a 505(b)(2) reformulated new drug designed as a liquid oral treatment for diabetes insipidus and has now completed all development stages required for the NDA submission in the United States.

EASYWELL stated that TLX-041 is currently the only FDA-approved oral liquid formulation of desmopressin, offering low-dose, precise, and adjustable dosing that specifically meets the treatment needs of pediatric patients. Citing data from IQVIA, a leading market research firm, the sales of such drugs for diabetes insipidus are projected to exceed US$68 million (approximately NT$2.18 billion) in 2024.

The drug was jointly developed by Tulex Pharmaceuticals and U.S. Nasdaq-listed Eton Pharmaceuticals. Eton is a pharmaceutical company focused on the development and commercialization of 505(b)(2) drugs for rare diseases. The company has already secured multiple FDA approvals and its pipeline includes both innovative reformulated drugs and niche medications that address large markets yet to receive formal FDA approval.

EASYWELL further noted that under the partnership, Tulex is responsible for drug formulation development and manufacturing, while Eton will cover development-related costs, manage the NDA submission process, and hold commercialization rights outside of Asia.

EASYWELL added that in addition to receiving milestone payments during the development process, Tulex will also be entitled to a share of future product profits and retains the rights to market the product in the Asian region.

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