ICER evidence report on obeticholic acid in NASH

22 July 2020

The USA’s Institute for Clinical and Economic Review (ICER) has released an Evidence Report assessing the comparative clinical effectiveness and value of obeticholic acid (OCA), from Intercept Pharmaceuticals (Nasdaq: ICPT), for the treatment of non-alcoholic steatohepatitis (NASH) with fibrosis.

Given the Food and Drug Administration’s recent Complete Response Letter (CRL) stating the treatment’s current efficacy and safety data were insufficient to support accelerated approval, the cost-effectiveness watchdog announced it will no longer hold the planned August 2020 public meeting to deliberate over the findings of this report.

“Although we do not know the reasons for the FDA decision, ICER’s review of OCA concluded that the potential cardiovascular risks of therapy led to uncertainties about whether treatment would be beneficial or harmful in many patients,” said Dr David Rind, the ICER’s chief medical officer.

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