FDA panel votes in favor of Gattex for SBS

FDA's Gastrointestinal Drugs Advisory Committee voted 12-0 that Gattex teduglutide from NPS Pharmaceuticals Inc. (NASDAQ:NPSP) is effective and that the benefits outweigh its risks for treating adults with short bowel syndrome (SBS). The panel concluded that Gattex's reduction in the proportion of patients achieving at least a 20% reduction in weekly parenteral nutrition volume from baseline to weeks 20 and 24 was clinically meaningful. Panel members also agreed with an FDA reviewer that the product's benefits outweigh the potential safety risks, including GI obstructions, biliary and pancreatic disorders, and acceleration of neoplasms. The committee voted 10-1, with one abstention, that NPS's proposed REMS is adequate to address the safety concerns. The analog of glucagon-like peptide-2 (GLP-2) has a Dec. 30 PDUFA date.

The panel's conclusions were in line with those expressed by an FDA reviewer in briefing documents released last week. Shares of NPS jumped $1.73 (19%) to $10.86 on Friday after the documents were published. Trading was halted on Tuesday (see BioCentury Extra, Oct. 12). ...