The FDA posted notes Friday for its upcoming Advisory Committee meeting, stating that the governing body is in agreement with NPS Pharmaceuticals (NASDAQ:NPSP) on the company’s risk-management plan for Gattex, which will be reviewed at the October 16th Gastrointestinal Drugs Advisory meeting. NPSP is up 18% in the late morning on the news, and investors speculate that the path to regulatory approval is now quite clear given the FDA’s actions; the agency will officially decide on Gattex’s approval on or before December 30.
Gattex is a treatment for Short Bowel Syndrome (SBS), and has shown clinical benefits in reducing parenteral nutrition and intravenous fluid volumes in adult subjects. SBS patients rely on intravenous feeding, as their gastrointestinal tract is unable to properly absorb nutrients. The New Drug Application for Gattex was accepted the drug for filing in January. While the advisory panel’s vote informs the final FDA regulatory decision, it does not determine the drug’s approval. You can see PropThink’s previous coverage here, in which we discuss the potential for a run-up into both the advisory panel date, and the PDUFA in late December.