Shots:
- The CHMP has recommended sebetralstat to treat acute attacks of hereditary angioedema (HAE) pts (≥12yrs.); EC’s decision expected by early Oct 2025. Application is under review in Japan & other regions
- Approval was based on P-III (KONFIDENT) study assessing sebetralstat (300mg & 600mg) vs PBO in 136 HAE pts (≥12yrs.) across 20 countries
- KONFIDENT data was published in The NEJM, which showed faster symptom relief, reduced attack severity & resolution
Ref: KalVista | Image: KalVista| Press Release
Related News:- KalVista Reports the MHRA Approval of Ekterly (Sebetralstat) for Treating Hereditary Angioedema
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