BioCryst Pharmaceuticals, Inc. Announces National Institute of Drug and Food Surveillance Grants Approval for Oral, Once-Daily ORLADEYO

Published: 2025-06-13 08:05:26 ET BCRX

Published on 06/13/2025 at 08:05

BioCryst Pharmaceuticals, Inc. announced that the National Institute of Drug and Food Surveillance (INVIMA) in Colombia has granted approval for oral, once-daily ORLADEYO®? (berotralstat) for the prophylaxis of hereditary angioedema (HAE) attacks in adults and pediatric patients 12 years of age or older. BioCryst has an exclusive collaboration with Pint Pharma GmbH to register and promote ORLADEYO in the pan-Latin America region.

Under the terms of the agreement, Pint is responsible for obtaining and maintaining all marketing authorizations and for commercializing ORLADEYO in LATAM. ORLADEYO has previously been approved in this region by regulatory agencies in Chile, Argentina, Brazil, Mexico and Peru.