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

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  • The US FDA has approved Ekterly (sebetralstat) to treat hereditary angioedema (HAE) pts (≥12yrs.), with US availability expected immediately
  • Approval was based on P-III (KONFIDENT) study assessing Ekterly (300mg & 600mg) vs PBO in 136 HAE pts (≥12yrs.) across 20 countries & KONFIDENT-S OLE study
  • KONFIDENT data was published in The NEJM, which showed faster symptom relief, reduced attack severity & resolution, while KONFIDENT-S showed early attack treatment with a median initiation time of 10min. & a 1.3hr median time to symptom relief for laryngeal, abdominal, & breakthrough attacks

Ref: Businesswire| Image: KalVista | Press Release

Related News:- KalVista Pharmaceuticals Partners with Kaken Pharmaceutical to Commercialize Sebetralstat in Japan

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