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FDA Grants Conatus Fast Track Designation for Development of Emricasan in NASH Cirrhosis

 

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Conatus Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company's emricasan development program for the treatment of liver cirrhosis caused by nonalcoholic steatohepatitis (NASH).

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 NASH cirrhosis, with parallel development toward registration of emricasan for patients with NASH fibrosis, and supportive clinical trials addressing additional patient populations.

The Fast Track program provides for greater access to FDA to facilitate development and expedite review of drugs that have demonstrated the potential to treat serious or life-threatening conditions. "The data from our recently completed Portal Hypertension trial, showing clinically meaningful reductions in hepatic venous pressure gradient (HVPG) in patients with severe portal hypertension after only one month of treatment with emricasan, were a key component of our Fast Track submission," said Conatus co-founder, President and Chief Executive Officer Steven J. Mento, Ph.D.

"The Fast Track designation formalizes the recognition of emricasan's potential to address a significant unmet medical need, but we believe its real importance is in the opportunity for even closer interactions with the FDA as we pursue the most efficient pathway to provide a potentially disease-modifying treatment to patients with NASH cirrhosis."

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