BioCryst Announces Approval of ORLADEYO® (berotralstat) by the Brazilian Health Regulatory Agency
RESEARCH TRIANGLE PARK, N.C., April 17, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Brazilian Health Regulatory Agency (ANVISA) 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.
- RESEARCH TRIANGLE PARK, N.C., April 17, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Brazilian Health Regulatory Agency (ANVISA) 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.
- “We are excited to announce that ORLADEYO is now approved in the region’s largest market, following the positive regulatory decisions we received in Chile and Argentina last year.
- We look forward to working with our partner, Pint Pharma, to make ORLADEYO available in Brazil and across LATAM,” 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.