Intercept’s NASH Drug Delayed By April Advisory Committee, But Firm Is Ready For Launch
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.
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With two new US investors on board, NST is financed to complete a Phase IIb trial of icosabutate in non-alcoholic steatohepatitis.
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.
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.