Cambridge, Mass.– KalVista Pharmaceuticals announced Friday that the U.S. Food and Drug Administration (FDA) will not meet its previously scheduled June 17 PDUFA (Prescription Drug User Fee Act) goal date for a decision on the company’s new drug application (NDA) for sebetralstat, an oral on-demand treatment for hereditary angioedema (HAE).
The FDA cited a heavy workload and limited resources as the reason for the delay but assured KalVista that a decision is still expected within the next four weeks. The agency has not requested any new data or raised concerns about the drug’s safety, efficacy, or potential for approval. KalVista noted that all prior information requests from the FDA have been addressed and that the remaining issue appears to be the finalization of product labeling.
“We are disappointed by this delay, most importantly because we know how much people living with HAE are looking forward to an oral on-demand option to treat their HAE attacks,” said KalVista CEO Ben Palleiko. “At the same time, we remain confident in the near-term approval of sebetralstat.”
Sebetralstat is a novel oral plasma kallikrein inhibitor designed to treat HAE attacks in patients aged 12 and older, with ongoing studies in children as young as two. If approved, it would become the first oral, on-demand treatment available for the rare and potentially life-threatening condition, which is marked by unpredictable swelling episodes.
KalVista has submitted regulatory filings in multiple regions, aiming to position sebetralstat as a foundational therapy in global HAE management.
