The FDA has delayed its decision to approve a new treatment for hereditary angioedema, citing a heavy workload and limited resources.
The drug, sebetralstat, developed by Kalvista Pharmaceuticals, was scheduled for a decision by June 17 under the Prescription Drug User Fee Act timeline, according to a June 13 news release from the drugmaker.
The FDA informed KalVista on June 13 that it would miss the target date but expects to issue a decision within four weeks. The company stated it is continuing to work with the FDA and expects a near-term approval.
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