US EditionOrsini Selected as Specialty Pharmacy Partner for KalVista's EKTERLY® (Sebetralstat)
UNITED STATES, JUL 7 – Ekterly offers faster symptom relief within 1.3 hours and allows a second dose within three hours, improving treatment flexibility for hereditary angioedema patients, analysts say.
- The FDA approved KalVista Pharmaceuticals' oral pill Ekterly on Monday to treat acute hereditary angioedema attacks in patients aged 12 and older.
- This approval followed a delayed FDA decision beyond the June 17 deadline and was based on positive Phase III KONFIDENT trial results showing faster symptom relief than placebo.
- The KONFIDENT trial included 136 patients across 66 sites in 20 countries and demonstrated a median symptom relief time of about 1.6 hours with Ekterly versus 6.7 hours for placebo.
- KalVista CEO Ben Palleiko called the approval a defining moment that enables patients to treat attacks at onset, while analyst Paul Matteis noted Ekterly's injectable-like efficacy could grow the stable on-demand HAE market.
- KalVista priced Ekterly at $16,720 per dose and granted commercialization rights for Japan in April 2025, aiming to deliver the first oral, on-demand HAE treatment widely to patients.
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KalVista Drug Gets FDA Approval for Treating Acute Swelling Attacks From Rare Disease
KalVista Pharmaceuticals’ Ekterly is now FDA approved for treating acute swelling attacks from hereditary angioedema. The KalVista tablet provides an alternative to injectable or infused HAE medications from companies such as Takeda Pharmaceutical and CSL Behring. The post KalVista Drug Gets FDA Approval for Treating Acute Swelling Attacks From Rare Disease appeared first on MedCity News.
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