The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) 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 MHRA-approved oral on-demand treatment for HAE attacks — painful and debilitating tissue swelling in various locations of the body. The drug is administered in tablet form, taken orally at the earliest sign of an attack.
Ekterly's approval is supported by KalVista’s phase 3 KONFIDENT trial, the largest clinical trial ever conducted in HAE. The trial, 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 shortly after the drug got the nod from the U.S. FDA, which came after rumors swirled that agency head Marty Makary initially directed staff members to issue a complete response letter.