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KalVista Reports the MHRA Approval of Ekterly (Sebetralstat) for Treating Hereditary Angioedema

Shots:The UK’s MHRA has approved Ekterly (sebetralstat) to treat hereditary angioedema (HAE) pts (≥12yrs.). Awaits approval in various global markets incl. the EU & Japan Approval was based on P-III (KONFIDENT) study assessing Ekterly (300mg & 600mg) vs PBO in 136 HAE pts (≥12yrs.) across 20 countries, which showed faster symptom relief, reduced attack severity &…
July 16, 2025

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KalVista Reports the US FDA’s Approval of Ekterly (Sebetralstat) for Treating Hereditary Angioedema

Shots:The US FDA has approved Ekterly (sebetralstat) to treat hereditary angioedema (HAE) pts (≥12yrs.), with US availability expected immediatelyApproval was based on P-III (KONFIDENT) study assessing Ekterly (300mg & 600mg) vs PBO in 136 HAE pts (≥12yrs.) across 20 countries & KONFIDENT-S OLE studyKONFIDENT data was published in The NEJM, which showed…
July 7, 2025

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CSL Receives the US FDA Approval for Andembry as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Shots:  The US FDA has approved Andembry (garadacimab-gxii) for HAE pts (≥12yrs); commercially available before Jun 2025 endApproval was based on P-III (VANGUARD) trial assessing Andembry (n=39) vs PBO (n=25) for 6mos., which showed 62% pts remained attack-free, with reduction in overall HAE attacks by >99% median & 89.2% mean, as well as attacks requiring…
June 17, 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…
December 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
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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…
August 31, 2022

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