Mirum Pharmaceuticals announces European Medicines Agency validation of the marketing authorisation application for maralixibat in patients with PFIC2

Mirum Pharmaceuticals

30 November 2020 - Five-year transplant-free survival data from the Phase 2 INDIGO study used as the basis for the MAA submission.

Mirum Pharmaceuticals today announced that the company’s marketing authorisation application for its investigational medicine, maralixibat, for the treatment of patients with progressive familial intrahepatic cholestasis type 2 (PFIC2), also known as bile salt export pump deficiency, was accepted for review (validated) by the European Medicines Agency.

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Michael Wonder

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Michael Wonder

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Medicine , Europe , Dossier