Heart drug passes crucial trial in the United States
- Source: Global Times
- [01:37 August 09 2010]
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By Liu Chang
A traditional Chinese Medicine made of herbal extracts and which treats angina, a cardiovascular condition, was tested to be safe and effective by the US Food and Drug Administration (FDA) and could be available in the US market in 2013 if future tests are successful.
Compound Danshen Dripping Pill, a Chinese medicine made of herbal extracts and produced by the Tianjin-based Tasly Pharmaceutical Company, said they got the word Saturday that Phase II clinical trials were successful. It is the first Chinese medicine that has passed the crucial test.
Once the medicine passes phase III, it will be eligible for FDA approval and for use by American patients. The drug won approval from authorities in Canada, Russia, South Korea, Vietnam, Singapore and some African countries.
To be approved by the FDA, a drug has to pass three phases of clinical trials, which take at least five years. No more than 20 medicines get such approval every year.
The first phase tests a drug or treatment on a small group of people, which usually lasts for 12 months. The second phase observes the effectiveness and side effects through tests on more than 100 patients, which takes two to three years. The last phase looks at the effectiveness of the drug after it is used by thousands of patients, which takes two to four years.
Yan Xijun, president of Tasly, told the Xinhua News Agency that the company would build 50 to 70 clinical trial centers worldwide for the third phase and he expected to see the pills in the US and in global drug markets within three years.
Wang Guoqiang, director of the State Administration of Traditional Chinese Medicine, was quoted as saying by China News Service that the country has exported $1.46 billion worth of Chinese medicine in 2009.
He said the advantages of traditional Chinese medicine in disease prevention and control is recognized in other countries.
