NASH Drug Development Guidance Encourages Sponsors To Adopt Innovative Trial Designs
Although guidance appears to be free of surprises, US FDA once again made a push for sponsors to adopt seamless trial designs.
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Having a confirmatory trial underway at the time of approval should be the ‘default expectation’ and the agency should publicly explain when and why it grants exceptions to this rule, experts said at a National Academies meeting on accelerated approval.
NGM’s Phase II data for FGF19 analog aldafermin shows ability to reduce liver fat and improve fibrosis, but also raises LDL-C. Company says it gets a broader effect this way and can manage the increased cholesterol.
None of the two-drug combinations tested by Gilead met statistical significance in the multi-arm non-alcoholic steatohepatitis trial. This follows the Phase III failure of selonsertib monotherapy earlier in 2019.