BioCryst Announces Approval of Orladeyo (berotralstat) by the Brazilian Health Regulatory Agency

Biocryst Pharmaceuticals Inc 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.

Charlie Gayer, Chief Commercial Officer of BioCryst, said: “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. This is an important moment for patients living with HAE in Brazil, as they will soon be able to access our oral, once-daily prophylactic therapy to help manage their condition. We look forward to working with our partner, Pint Pharma, to make Orladeyo available in Brazil and across LATAM.”

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)