Amicus Eyes Broad Future Label For Migalastat After Huge Filing Setback
Executive Summary
US FDA recommends company start a new study of oral Fabry disease drug, to be designed using the agency's irritable bowel syndrome guidance for measuring efficacy in diarrhea.
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FDA approved Galafold under accelerated approval, paving the way for the launch of the first oral therapy to treat a subset of patients with the rare condition Fabry disease. Amicus priced Galafold at $315,000 per year.
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