Daewha Pharmaceuticals said Friday that it has received approval for phase 2 clinical trials for injectable paclitaxel Liporaxel, relapsed or metastatic breast cancer treatment, from the U.S. Food and Drug Administration.
The company had filed an investigational new drug (IND) application with the FDA on Aug. 19.
Daewha대화제약 expects the FDA approval will serve as a stepping-stone for entering the U.S. market, the largest for breast cancer. It plans to file clinical trial ethics committee application with seven U.S. hospitals, including the University of California San Francisco, with the goal of registering its first patient by the end of this year.
Liporaxel is the world's first oral paclitaxel developed by Daewha with the support of the Ministry of Trade, Industry and Energy (MTIE)산업통상자원부 and the Korea Evaluation Institute of Industrial Technology한국산업기술평가관리원. The treatment received approval for phase 2 and 3 domestic clinical trials this month.
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