KalVista Pharmaceuticals announced regulatory approval in its US homeland on 7 July for Ekterly (sebetralstat), the first oral PKK inhibitor for acute hereditary angioedema (HAE) attacks in patients aged ≥12 years. The approval was based on Phase III KONFIDENT trial data showing faster symptom relief (1.61 hours vs 6.72 hours placebo) and complete resolution within 24 hours (49.5% vs 27.4% placebo) at the 600 mg dose.

Ekterly fills an unmet need as the only oral on-demand HAE treatment, compared to five existing injectable options. It inhibits PKK-mediated bradykinin overproduction caused by C1 esterase inhibitor deficiency. The drug's rapid onset (median 10-minute treatment delay post-attack in KONFIDENT-S) offers convenience over intravenous/subcutaneous alternatives like ecallantide or icatibant.