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Traditional Chinese medicine seeks to receive FDA approval in US

1st April 2013


ICON plc, a provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, has announced that it has been selected by Tasly Pharmaceuticals for the company’s global Phase III T89 trial. T89, also known as Dantonic pill, aims to become the first traditional Chinese medicine to receive FDA approval in the United States.

Dantonic 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 is conducting two global Phase III trials for the Dantonic 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.

“Dantonic pill global Phase III studies are pioneering projects. There are a number of innovative components in the R&D of this drug,” commented Dr Henry Sun, President of Tasly Pharmaceuticals, Inc., and Vice President of Tasly Group. “When choosing a CRO for these important Phase III trials we sought a company that had a large global infrastructure supported by the most advanced regional testing facilities. In ICON we have found a trusted development partner with all of these attributes and one that also has a strong reputation for delivering quality clinical programmes.”

“ICON is proud to play an important role in helping advance the globalisation of traditional Chinese medicine,” commented Dr. Malcolm Burgess, Executive Vice President, ICON Clinical Research. “Through our experience of managing studies in all major geographies, we have established solid working relationships with the world’s leading investigators and our regional testing facilities are strategically located to support global trials. We look forward to working with Tasly and to helping them in their efforts to become the first provider of an FDA-approved traditional Chinese medicine.”

For more information, visit www.tasly.com or www.iconplc.com




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