The U.S. FDA will not meet KalVista Pharmaceuticals’ PDUFA goal date for its New Drug Application (NDA) for sebetralstat, an investigational oral on-demand treatment for hereditary angioedema (HAE).
KalVista shared the news in a press release, revealing that agency notified the company on June 13 that the previously disclosed June 17 PDUFA goal date will not be met due to “heavy workload and limited resources.” The FDA indicated that it expects to deliver a decision within approximately four weeks.
The FDA has not requested additional data or studies and has not raised any concerns regarding the safety, efficacy or approvability of sebetralstat.
KalVista’s sebetralstat is a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of HAE attacks — painful and debilitating tissue swelling in various locations of the body.
If approved, sebetralstat will be the first oral, on-demand treatment for HAE in patients aged 12 years and older. In the company’s phase 3 KONFIDENT trial, the largest clinical trial ever conducted in HAE, the median time to beginning of symptom relief was 1.61 hours with sebetralstat 300 mg tablets and 1.79 hours with sebetralstat 600 mg tablets.