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.
“Today’s announcement marks another important step toward bringing ORLADEYO to people living with HAE who are in need of new treatment options across the pan-Latin America region. Following this positive decision from INVIMA, we are working with the team at Pint Pharma to bring our oral, once-daily prophylactic therapy to patients in Colombia,” said Charlie Gayer, chief commercial officer of BioCryst.
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.
About ORLADEYO® (berotralstat)
ORLADEYO® (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older. One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.
