KalVista Pharmaceuticals, Inc. (KALV), Friday announced that the European Commission and Swiss Agency for Therapeutic Products, Swissmedic, have approved EKTERLY for the symptomatic treatment of acute attacks of hereditary angioedema in adults and adolescents aged 12 years and older.
The approvals are based on the findings from the phase 3 KONFIDENT clinical trial, showing that EKTERLY achieved significantly faster symptom relief, reduction in attack severity and attack resolution than placebo, and was well-tolerated with a safety profile similar to placebo.
Following this, the company is working with local regulatory authorities and health technology assessment bodies across the EU and Switzerland to avail access to EKTERLY.
Meanwhile, the company plans to initiate its first European launch in Germany in the fourth quarter of 2025, with availability in Switzerland anticipated in the second half of 2026.
In the pre-market hours, KALV is trading at $14, up 0.86 percent on the Nasdaq.
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