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 & CanadaNDA was supported by P-III (APeX-P) trial assessing Orladeyo…

ByRidhi RastogiMay 16, 2025

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CSL Behring’s Andembry (Garadacimab) Receives Positive CHMP Opinion to Treat Hereditary Angioedema (HAE)

Shots: The CHMP has recommended Andembry as a prophylactic treatment of HAE in patients (≥12 yrs.), with the EC’s decision anticipated in Q1’25, based on P-III (VANGUARD) trial & ongoing OLE study The P-III study (full results published in The Lancet) of Andembry vs PBO met its 1EP, showing attack-free status in 62% while…

ByDipanshu DixitDecember 13, 2024

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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 HAEThe interview gives an understanding of BioCryst’s vision to develop medicines that treat rare diseases for unmet…

BySenior EditorAugust 31, 2022

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

CSL Behring’s Andembry (Garadacimab) Receives Positive CHMP Opinion to Treat Hereditary Angioedema (HAE)

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

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

CSL Behring’s Andembry (Garadacimab) Receives Positive CHMP Opinion to Treat Hereditary Angioedema (HAE)

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

FOLLW US

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