NASH Drug Development Questions? US FDA Has Many Of The Answers

The US Food and Drug Administration was deluged with questions during a webinar on the development of new drugs to treat non-alcoholic steatohepatitis (NASH), showing how hot the area is in pharma R&D and the issues of concern to sponsors, from the use of biomarkers to the length of trials.

In opening the 29 January webinar, Toru Matsubayashi, a medical reviewer in the Division of Hepatology and Nutrition, noted some unique challenges inherent in drug development for NASH. He said...