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Diseases

KalVista Pharmaceuticals Secures FDA Approval for HAE Treatment Ekterly

Strategic Insights

— 2 min read

KalVista Pharmaceuticals has overcome regulatory hurdles to secure FDA approval for its plasma kallikrein inhibitor sebetralstat, now commercially known as Ekterly. The oral treatment has been approved for managing acute attacks of hereditary angioedema (HAE) in adults and children aged 12 and above. This breakthrough comes after the FDA initially missed its June 17 target decision date due to a heavy workload and limited resources, sparking industry concerns about the agency's regulatory capacity. Despite this setback, KalVista is pressing forward with plans to launch Ekterly in the US "immediately," marking its first commercially approved product. Ekterly's approval marks a significant moment for people living with HAE, as it allows for swift treatment of debilitating attacks.

Key Takeaways:

  • KalVista Pharmaceuticals has secured FDA approval for its plasma kallikrein inhibitor sebetralstat, now known as Ekterly, for the management of acute attacks of hereditary angioedema (HAE) in adults and children aged 12 and above.
  • Ekterly's approval follows a missed June 17 target decision date due to the FDA's heavy workload and limited resources, sparking concerns about the agency's regulatory capacity.
  • The oral treatment represents KalVista's first commercially approved product and has the potential to become a foundational treatment for HAE due to its simplified on-demand dosing.
  • The FDA's approval was based on data from KalVista's phase 3 KONFIDENT trial, demonstrating Ekterly's efficacy in providing symptom relief, reducing attack severity, and resolving attacks compared to placebo.
  • KalVista has also presented data from an open-label extension trial, showing that patients treated with Ekterly experienced symptom relief within a median window of 10 minutes following attack onset.
  • The fact that Ekterly can be taken orally, offering a convenient treatment alternative to existing injectable or intravenous treatments, is expected to improve treatment compliance and outcomes for patients with HAE.
  • The FDA's commissioner, Marty Makary, M.D., has been the subject of controversy following reports that he may have sought to reject Ekterly's approval.

Statistics:

  • 10 minutes: the median time it took for patients treated with Ekterly to start experiencing symptom relief in an open-label extension trial (KONFIDENT-S).
  • 1.3 hours: the median time it took for patients on Ekterly to start experiencing symptom relief for attacks involving the larynx or abdomen.
  • 60-90 days: the expected launch timeline for Ekterly in the US.

Sources:

  • KalVista Pharmaceuticals press release, July 7, 2023
  • University of California, San Diego's Marc Riedl, M.D., investigator on the pivotal trial that secured Ekterly's approval
  • Endpoints News, internal communications at the FDA
  • Department of Health and Human Services (HHS) spokesperson

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