Tasly Pharmaceuticals Selects ICON as it Seeks First FDA Approval of a Traditional Chinese Medicine
ICON
announced that it has been selected by
Tasly Pharmaceuticals
for the company’s global Phase III T89 trial. T89, also known as DantonicÒ pill, aims to become the first traditional Chinese medicine to receive FDA approval in the United States.
DantonicÒ pill is a botanical product for the treatment of chronic stable angina pectoris due to coronary heart disease. It is a modernised version of a traditional Chinese herbal medicine and was approved by the State Food and Drug Administration (SFDA) of China in 1993. Since then, more than 2 billion doses have been used by over 10 million patients.
Tasly Pharmaceuticals Inc., the fully-owned subsidiary of China based Tasly Pharmaceuticals Co. Ltd., a public company, is conducting two global Phase III trials for the DantonicÒ pill. ICON has been awarded the 3-arm Phase III clinical trial and will also be providing IVRS, data management and central laboratory services for both global trials.
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