US EditionOrsini Selected as Specialty Pharmacy Partner for KalVista's EKTERLY® (Sebetralstat)
UNITED STATES, JUL 7 – Ekterly offers faster symptom relief and higher attack resolution rates in hereditary angioedema patients aged 12+, based on Phase 3 trials, after FDA approval delay due to resource limits.
- The FDA approved KalVista Pharmaceuticals' Ekterly pill on Monday as the first oral treatment for acute hereditary angioedema attacks in patients aged 12 and older.
- The approval followed the successful Phase III KONFIDENT trial completed in December 2023, which showed Ekterly significantly sped symptom relief and attack resolution over placebo.
- Ekterly allows patients to begin treatment within a median of 10 minutes of attack onset and offers a second dose option within three hours, improving independence and control.
- KalVista CEO Ben Palleiko called the FDA approval a "defining moment for people living with HAE" and highlighted the company's commitment to delivering this innovative option.
- KalVista granted commercialization rights for Ekterly in Japan to Kaken Pharmaceutical in April 2025 with an $11 million upfront payment, focusing on broad patient access.
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26 Articles
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.
FDA Approves Ekterly: A New Oral Option for Hereditary Angioedema Attacks – Patient Worthy
A significant advancement for people living with hereditary angioedema (HAE) arrived with the recent FDA approval of Ekterly (sebetralstat), the first oral on-demand therapy designed to treat acute HAE attacks in adults and children aged 12 and older. This new option, developed by KalVista Pharmaceuticals, marks a promising shift away from injectable treatments, offering greater […]
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