BioCryst announces approval of Orladeyo (berotralstat) by the National Administration of Drugs, Foods and Medical Devices (ANMAT) in Argentina
BioCryst Pharmaceuticals Inc. today announced that the National Administration of Drugs, Foods, and Medical Devices (ANMAT) in Argentina 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.
Charlie Gayer, Chief Commercial Officer of BioCryst, said: “We continue to make strides to bring Orladeyo to patients living with HAE in Latin America in collaboration with our partner, Pint Pharma. We applaud ANMAT’s decision to grant approval to our oral, once-daily prophylactic therapy for HAE, which paves the way for patients living with HAE to receive Orladeyo to help improve management of their HAE attacks.”
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.
(Source: BioCryst)
