Intercept’s Early NASH Efforts Will Stress Advanced Fibrosis
Intercept said its commercial groundwork in NASH centered on identifying doctors who treat patients with advanced fibrosis and talking to payers about the importance of preventing cirrhosis.
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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.
Intercept announced that the US FDA has set April 22 as date for an advisory committee review of OCA in NASH, meaning March 26 action date could be pushed back as much as three months.