FDA Approval of EKTERLY
EKTERLY was approved by the FDA as the first and only oral on-demand therapy for acute HAE attacks in adults and pediatric patients aged 12 and older, marking a significant advancement in treatment options for HAE.
Strong Early U.S. Launch Metrics
EKTERLY's U.S. launch saw almost 5% of the entire U.S. HAE population submitting a prescription, indicating strong early demand and rapid uptake among patients and healthcare providers.
Positive European Regulatory Progress
Sebetralstat received a positive CHMP opinion in Europe, with a final decision expected in October, and was granted 10 years of market exclusivity, indicating strong potential for international market entry.
Revenue Generation
KalVista reported $1.4 million in net revenue from EKTERLY sales during the launch period, indicating initial financial success from the product launch.
Broad Patient and Prescriber Engagement
Over 460 patient start forms were received, and 253 unique prescribers were activated, showcasing broad interest and engagement from both patients and healthcare providers.