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BioCryst
NEWS

BioCryst Pharmaceuticals Reports MHLW Approval of Orladeyo for Hereditary Angioedema

Shots: The MHLW has approved Orladeyo (berotralstat) for prophylactic therapy in pediatric pts (2 to <12 yrs.) with hereditary angioedema (HAE) Approval was based on interim APeX-P trial results in pediatric pts with HAE, which showed early & sustained reductions in monthly attack rates; published in the Annals of Allergy, Asthma & Immunology BioCryst plans to launch…
August 26, 2026

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BioCryst
NEWS

BioCryst Reports the US FDA’s NDA Acceptance and Priority Review of Orladeyo for Hereditary Angioedema (HAE)

Shots: The US FDA has accepted NDA & granted priority review to Orladeyo (berotralstat) for the treatment of HAE pts (2-11yrs.), with PDUFA action date of Sep 12, 2025. Line extension application has been filed with the EMA; further filings are planned globally incl. Japan & Canada NDA was supported by P-III (APeX-P) trial assessing Orladeyo…
May 16, 2025

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George Stanley, Medical Director for the UK & Ireland at BioCryst Shares Insights from Long-Term Study Data at EAACI 2022
VIEWPOINTS

George Stanley, Medical Director for the UK & Ireland at BioCryst Shares Insights from Long-Term Study Data at EAACI 2022

Shots: George spoke about the 96-week data from the P-III APeX-2 trial evaluating BioCryst’s lead candidate in Hereditary Angioedema (HAE)  He also talked about various patient support programs from BioCryst to help patients with self-management of their HAE The interview gives an understanding of BioCryst’s vision to develop medicines that treat rare diseases for unmet…
August 31, 2022

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