Yesterday, shares of Conatus Pharmaceuticals (CNAT) closed the day up 22% after the company announced that the FDA had granted the company’s drug, Emricasan, FDA fast track status for NASH Cirrhosis. The company has been in back and forth talks between the FDA to achieve this fast track status. Both have agreed to start Conatus off in a trial with NASH Cirrhosis, and then begin a trial for NASH fibrosis.
The company was able to obtain this fast track status because it submitted data from a previous trial that treated patients with portal hypertension. This trial showed remarkable efficacy after only one month of treatment with Emricasan. It seems the FDA was quite impressed and thus the FDA fast track status was given.
Fast track is given to companies that develop drugs for unmet medical needs. Such a status gives companies the ability to get drugs approved at a quicker pace than normal. For instance, these fast track drugs get advanced review ahead of many other drugs. In addition, there is more frequent communication between the FDA and particular company. This allows the company to resolve problems or questions in a timely manner.
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