Madrigal Pharmaceuticals’ NDA for resmetirom accepted by FDA
Madrigal Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for resmetirom for the treatment of adult patients with nonalcoholic steatohepatitis (NASH) with liver fibrosis.
The FDA has granted the drug Priority Review and designated a Prescription Drug User Fee Act date for 14 March 2024 – this is the target date by which the FDA should have completed its review process.
The drug is a once-daily, oral, thyroid hormone receptor (THR)-β selective agonist designed to target the underlying causes of NASH in the liver. The development programme includes 18 clinical studies to support the NDA, 12 of which are phase 1, two phase 2 and four phase 3.
Bill Sibold, Madrigal’s CEO commented: “NASH with liver fibrosis represents a significant unmet need in healthcare today: the disease has a serious impact on patients and, without treatment, it can lead to increased risk of cirrhosis, liver failure, liver cancer and premature mortality. Resmetirom is a liver-directed therapy that has demonstrated the potential to treat the liver fibrosis that is associated with these negative outcomes, while resolving the underlying steatohepatitis that drives the disease. The FDA’s acceptance of our NDA with priority review is an important step forward as we pursue our goal of delivering the first approved treatment to patients with NASH with liver fibrosis.”
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