07:55 AM EDT, 08/11/2025 (MT Newswires) -- KalVista Pharmaceuticals ( KALV ) said Monday its oral plasma kallikrein inhibitor, sebetralstat, has received maintenance of orphan designation from the Committee for Orphan Medicinal Products, or COMP, of the European Medicines Agency.

The Committee for Medicinal Products for Human Use issued a positive opinion for sebetralstat for treating acute attacks of hereditary angioedema, the company said, adding that a final decision from the European Commission is expected by early October.

The COMP decision was based on findings that sebetralstat offers "comparable efficacy" to injectable on-demand treatments while reducing morbidity from hereditary angioedema attacks, KalVista said. The designation provides regulatory and financial benefits, including 10 years of market exclusivity in the EU after approval.