KalVista Pharmaceuticals (KALV) said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended marketing authorization for sebetralstat for symptomatic treatment of acute attacks of hereditary angioedema.
Final decision from the European Commission is expected by early October, the company said.
Hereditary angioedema, or HAE, is a rare, genetic and potentially life-threatening disease that can lead to painful and debilitating attacks of tissue swelling in various locations of the body.
The European regulator based its opinion on the phase 3 clinical trial showing that sebetralstat led to faster symptom relief and reduced attack severity and attack resolution than placebo, with a well-tolerated safety profile similar to placebo, KalVista said.
Sebetralstat is approved in the US and United Kingdom under the brand name Ekterly for treatment of people with HAE 12-years-old and older.
The company's shares were up more than 1% in recent premarket activity Friday.
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