FDA won’t meet PDUFA goal date for sebetralstat

The US Food and Drug Administration (FDA) has notified KalVista Pharmaceutical (Nasdaq: KALV) that it will not meet the Prescription Drug User Fee Act (PDUFA) goal date for the New Drug Application (NDA) for sebetralstat, the company’s investigational oral on-demand treatment for hereditary angioedema (HAE).

The FDA notified the USA and UK-based company on June 13, after market’s closed, 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 has addressed all prior information requests in a timely manner, and the company believes the only remaining item under FDA review is the finalization of the labelling.