KalVista Reports the US FDA’s NDA Acceptance of Sebetralstat for Treating Hereditary Angioedema (HAE)
Shots:
- The US FDA has accepted NDA for sebetralstat to treat HAE (PDUFA: Jun 17, 2025), with EMA validating its MAA for the same. Further filings across the UK, Japan & other regions are planned in H2’24
- Submission was based on P-III (KONFIDENT) study of sebetralstat (300mg & 600mg) vs PBO in HAE patients (≥12yrs.), showing faster symptom relief & ongoing KONFIDENT-S open label extension study, showing early attack treatment with a median time of 9mins. & a median time to symptom relief for laryngeal attacks of 1.3hrs.
- KalVista’s KONFIDENT-KID study assessing the safety, PK & efficacy of sebetralstat using pediatric oral disintegrating tablet (ODT) formulation in children (n=24; 2 to 11yrs.) for 1yr. has begun
Ref: KalVista Pharmaceuticals | Image: KalVista Pharmaceuticals
Related News:- KalVista Pharmaceuticals Highlights Results from the P-III (KONFIDENT) Study of Sebetralstat for Hereditary Angioedema
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
