Posted by Michael Wonder on 20 Dec 2016
FDA grants Conatus fast track designation for development of emricasan in NASH cirrhosis
3 February 2016 - Conatus Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to the company's emricasan development program for the treatment of liver cirrhosis caused by nonalcoholic steatohepatitis.
Based on additional communications with the FDA recommending single-etiology clinical trials, the company plans to focus on advancing toward initial registration of emricasan for patients with nonalcoholic steatohepatitis (NASH) cirrhosis, with parallel development toward registration of emricasan for patients with NASH fibrosis, and supportive clinical trials addressing additional patient populations.
