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Wednesday, September 12, 2018
RedHill Biopharma announces meeting with FDA for colitis med
RedHill Biopharma announced that it recently concluded a positive end-of-Phase II/pre-Phase III meeting with the FDA discussing the clinical and regulatory pathway towards potential U.S. approval of Bekinda for the treatment of diarrhea-predominant irritable bowel syndrome , or IBS-D. In light of the clarity provided by the FDA, RedHill plans to finalize the design of two pivotal Phase III studies with Bekinda and to accelerate global pharma partnership discussions, including U.S. co-promotion opportunities. The FDA meeting followed the positive results of the randomized, double-blind, placebo-controlled Phase II study with Bekinda for IBS-D. The study, which was conducted in the U.S. and enrolled 126 subjects, successfully met its primary endpoint, improving the primary efficacy outcome of stool consistency response by an absolute difference of 20.7% vs. placebo.
https://thefly.com/landingPageNews.php?id=2789079
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