Gattex teduglutide regulatory update

NPS said FDA accepted for review an sNDA to update the label of Gattex teduglutide for short bowel syndrome (SBS) to include long-term data from the open-label STEPS 2 extension trial. The PDUFA date is June 28. STEPS 2 is an extension of the double-blind, placebo-controlled, international Phase III STEPS trial, in which Gattex met the primary endpoint of a greater proportion of patients who achieved a >=20% reduction in weekly parenteral nutrition volume from baseline to week 20 and maintained that response at week 24 vs. placebo (63% vs. 30%, p=0.002) (see BioCentury, Feb. 7, 2011). ...