ARTICLE | Clinical News

Tasly, FDA discuss approval path for Chinese medicine product

September 8, 2017 7:25 PM UTC

FDA will require Tasly Pharmaceutical Co. Ltd. (Shanghai:600535) to conduct an additional Phase III trial before it submits an NDA for Dantonic (T89), which could be the first traditional Chinese medicine to receive FDA approval as a prescription drug. The company said it is in ongoing discussions with FDA regarding the new trial.

Tasly and FDA met to discuss the potential of an accelerated approval of Dantonic to prevent and treat stable angina based on results of the 960-patient Phase III CAESA trial. Compared to placebo, Dantonic narrowly missed CAESA's primary endpoint of improving total exercise duration (TED) at week 4 (p=0.06), but met the secondary endpoint of TED improvement at week 6 (p=0.02). Tasly said it also discussed with FDA regulatory pathways for the product to treat acute altitude sickness and diabetic retinopathy, indications for which it has undergone clinical testing in China...

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Tasly Pharmaceutical Co. Ltd.