Press release
KalVista Pharmaceuticals Announces Maintenance of Orphan Designation for Sebetralstat in European Union
Sebetralstat is one of only two hereditary angioedema therapies to maintain orphan designation, underscoring its major contribution to patient care If
About this update from Kalvista Pharmaceuticals, Inc.
[{"type":"text","content":"\nSebetralstat is one of only two hereditary angioedema therapies to maintain orphan designation, underscoring its major contribution to patient care\n\n\nIf approved, sebetralstat will be granted 10 years of market exclusivity in EU\n\n\n CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--\nKalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) confirmed maintenance of orphan designation for sebetralstat, underscoring the critical unmet need that sebetralstat addresses in the European Union (EU). Sebetralstat, a novel, oral plasma kallikrein inhibitor, has received a positive CHMP opinion for the treatment of acute attacks of hereditary angioedema (HAE), and the European Commission (EC) final decision is expected by early October.\n\n\n“We are pleased with the decision to maintain EU orphan designation for sebetralstat, which is an uncommon achievement that reflects the significant benefits sebetralstat offers,” said Ben Palleiko, CEO of KalVista. “Orphan status provides benefits that will support the commercialization of sebetralstat in the EU, including 10 years of market exclusivity, as we continue our efforts to bring this important new treatment option to people living with HAE around the world.”\n\n\nThe decision to maintain orphan designation was based on a finding of comparable efficacy of sebetralstat to injectable on-demand treatments while offering a major contribution to patient care by reducing the morbidity of HAE attacks. Maintenance of orphan designation provides several important regulatory and financial benefits, including 10 years of market exclusivity in the EU following approval. Notably, sebetralstat is now one of only two HAE medicines to have maintained orphan designation in the EU, highlighting its distinctive position within the HAE treatment landscape.\n\n\n“Maintaining orphan designation for sebetralstat is a recognition of the meaningful impact this therapy can have on people living with HAE,” said Mauro Cancian, MD, PhD, Head of the Allergy Division at the University of Padua in Padova, Italy. “With currently available injectable therapies, many patients delay or avoid treatment due to the hassle and fear of injection-site reactions, often suffering through attacks longer than they need to. Or...