KalVista Plans Quick FDA Filing After Phase III Success In On-Demand HAE Therapy

 
• By Joseph Haas
  
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The firm’s oral kallikrein inhibitor might offer a better overall profile for on-demand treatment than currently approved therapeutic and prophylactic agents, analysts said.

Rare Diseases
KalVista hopes it has the latest advance in rare disease HAE • Source: Shutterstock

About 15 months after ending development of a different hereditary angioedema candidate due to liver safety worries, KalVista Pharmaceuticals, Inc. reported what analysts called best-case scenario results for its Phase III oral kallikrein inhibitor sebetralstat (KVD900) on 13 February. With the data in hand, KalVista said it plans to file sebetralstat for on-demand therapy in HAE by midyear, with expectations that it might become a foundational treatment for the rare swelling disorder.

“We believe that sebetralstat is positioned to open a new era of HAE therapy that could become the foundational treatment...

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