Tuesday, May 23, 2023
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Public Health Institute (ISP) of Chile has granted marketing authorization for oral, once-daily ORLADEYO® (berotralstat) for the prophylaxis of hereditary angioedema (HAE) attacks in patients 12 years of age or older.
“Today’s announcement marks the first approval of ORLADEYO in Latin America, which is an important step forward in addressing the significant unmet needs of hereditary angioedema patients who live in the region. With this approval, we continue our mission to bring ORLADEYO to patients around the world who could benefit from an oral, once-daily prophylactic treatment option to improve control of their HAE attacks,” 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 the region.