The U.S. FDA has approved KalVista Pharmaceuticals’ novel plasma kallikrein inhibitor, branded Ekterly, for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.
Ekterly is the first and only oral on-demand treatment for HAE attacks — painful and debilitating tissue swelling in various locations of the body.
In KalVista’s phase 3 KONFIDENT trial, the largest clinical trial ever conducted in HAE, the median time to beginning of symptom relief was 1.61 hours with Ekterly 300 mg tablets and 1.79 hours with Ekterly 600 mg tablets.
The approval comes after some FDA controversy. Back in mid-June, KalVista revealed that the agency notified the company on June 13 that the previously disclosed June 17 PDUFA goal date will not be met due to “heavy workload and limited resources.” Days after that news was shared, rumors began to swirl that FDA staff members involved with KalVista’s application had received directives from agency head Marty Makary to issue a complete response letter. Sources noted that the request was met with numerous objections, and ultimately was withdrawn by Makary.
KalVista says it will launch Ekterly in the U.S. immediately and physicians can begin writing prescriptions today.