Mirum Targets $500m Sales For Just-Approved Rare Liver Disorder Drug
FDA Green Light For Alagille Syndrome Therapy Livmarli
Regulators have approved Mirum's IBAT inhibitor as the first medication for a genetic disorder which affects up to 2,500 children in the US.
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Sponsors of three drugs have withdrawn their EU marketing authorization applications in the middle of the assessment process, including one for a bladder cancer therapy that was recently turned down in the US.
The company anticipates an addressable global market for progressive familial intrahepatic cholestasis of 2,500 patients, with initial plans to focus on around 100 physicians at 60 centers.