The FDA has approved Ekterly, the first oral treatment for hereditary angioedema. With the approval, the drug is now cleared for treatment in adults and children ages 12 and older.
Before Ekterly, all approved on-demand treatments for hereditary angioedema required intravenous or subcutaneous injections, according to a July 7 news release from the drugmaker.
The approval comes after the medication faced an unexpected delay last month, with KalVista citing the FDA’s “heavy workload and limited resources.”
The approval is based on data from a large clinical trial, which showed faster symptom relief and reduced attack severity compared to a placebo. An ongoing extension study reported patients began treatment within 10 minutes of symptom onset with median symptom relief beginning at 1.3 hours for some severe attacks.
