KalVista (KALV) announced that the Committee for Orphan Medicinal Products of the European Medicines Agency confirmed maintenance of orphan designation for sebetralstat, underscoring the critical unmet need that sebetralstat addresses in the European Union. Sebetralstat, a novel, oral plasma kallikrein inhibitor, has received a positive CHMP opinion for the treatment of acute attacks of hereditary angioedema, and the European Commission final decision is expected by early October.
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