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

 
• By Joseph Haas

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 for people living with HAE, offering them an effective, safe and discreet way to treat HAE attacks without the challenges of injectables or the chronic

Key Takeaways

  • KalVista’s sebetralstat met all endpoints for treating and resolving HAE attacks in a Phase III trial.

  • The company plans to file for approval in the US during the first half of 2024, to be followed by EU and Japan filings

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