ICER revised evidence report on NASH treatments

The USA’s Institute for Clinical and Economic Review (ICER) has posted its revised  Evidence Report assessing the comparative clinical effectiveness and value of Madrigal Pharmaceuticals (Nasdaq: MDGL) resmetirom and Intercept Pharmaceuticals’ (Nasdaq: ICPT) obeticholic acid (OCA) for non-alcoholic steatohepatitis (NASH).

Madrigal and Intercept are leading the race to gain approval for the first NASH treatment, an area where others have so far failed. OCA is due to be reviewed by a US regulator advisory committee next month.

“NASH is increasingly common and lacks good therapies,” said Dr David Rind, the ICER’s chief medical officer, adding: “While many with NASH will remain asymptomatic, some individuals will progress to severe liver disease and experience the complications of cirrhosis, hepatocellular cancer, and/or require liver transplantation. NASH is also a marker for increased cardiovascular risk and one of these therapies, resmetirom, improves lipids, while the other therapy, obeticholic acid, worsens lipids and also causes itching in many patients. If these drugs receive FDA approval, while awaiting long-term liver and cardiovascular data, patients and doctors will need to balance the risks, burdens, and potential benefits of each of these therapies.”