KalVista Highlights Unmet Needs in Pediatric HAE Treatment with New Data
Event summary
- KalVista presented new data at ISPOR 2026 and EAC highlighting the burden of injectable on-demand treatments for children aged 2–11 with hereditary angioedema (HAE).
- Real-world claims data showed that while two-thirds of children were prescribed IV pdC1INH, the majority utilized off-label icatibant, suggesting a preference for less invasive options.
- A caregiver survey found that 93.7% of children experienced anxiety about using injectable treatments, with 75% reporting side effects such as pain and burning.
- KalVista plans to submit a new drug application for sebetralstat in children aged 2–11 in Q3 2026, positioning EKTERLY® as the first oral on-demand therapy for this age group.
The big picture
KalVista's data underscores the significant unmet needs in pediatric HAE treatment, particularly the challenges associated with injectable therapies. The push for an oral on-demand treatment like EKTERLY® aligns with broader industry trends toward patient-friendly, non-invasive solutions for rare diseases. If approved, sebetralstat could become a foundational therapy for HAE management, addressing both pediatric and adult populations.
What we're watching
- Regulatory Approval
- Whether KalVista's sebetralstat will secure FDA approval for the pediatric population by the end of 2026, expanding its market potential.
- Market Adoption
- The pace at which EKTERLY® can gain acceptance as the preferred oral on-demand treatment for HAE, given the high caregiver and patient anxiety around injectables.
- Clinical Trial Progress
- How the ongoing KONFIDENT-KID trial will impact the safety and efficacy data for sebetralstat in pediatric patients, influencing future regulatory decisions.
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