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 & resolution; data was published in The NEJM
- Additionally, Ekterly met MHRA’s Orphan Designation criteria & secured up to 10yrs. of market exclusivity, plus will remain available via EAMS until a NICE decision, which is expected in H1’26 on its use under NHS
Ref: KalVista | Image: KalVista| Press Release
Related News:- KalVista Reports the US FDA’s Approval of Ekterly (Sebetralstat) for Treating Hereditary Angioedema
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