Shots:
- The EC and Swissmedic have approved Ekterly to treat acute HAE attacks in pts (age≥12) across EEA states. Launch is expected in Germany in Q4’25 and in Switzerland in H2’26
- Ekterly’s approval by the EC and Swissmedic was based on the P-III (KONFIDENT) trial. Published in NEJM (May 2024), results showed significantly faster symptom relief, reduced attack severity, and resolution vs. PBO, with a well-tolerated safety profile. The trial included 136 pts across 20 countries
- Ekterly, plasma kallikrein inhibitor, is approved in the US, EU, UK, and Switzerland for treating HAE attacks
Ref: KalVista | Image: KalVista| Press Release
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