Maralixibat on path to new drug application for Alagille syndrome-pruritus

Mirum Pharmaceuticals completed a clinical pre-new drug application meeting with the FDA for maralixibat, the company’s therapeutic candidate for the treatment of Alagille syndrome-associated pruritus, according to a press release.“We are pleased that the FDA recommended that we change the classification of our requested Type C meeting to a pre-NDA meeting and that we have a path to a rolling NDA submission for maralixibat beginning in the third quarter of 2020,” Chris Peetz, president and CEO of Mirum, said in the release. “We look forward to working with the FDA toRead More

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