Gattex regulatory update

NPS said FDA extended the PDUFA date by 3 months for an NDA for Gattex teduglutide to treat short bowel syndrome (SBS). The new date is Dec. 30; it was Sept. 30. According to NPS, FDA needed more time to review information submitted by the company at the agency's request. NPS would not provide details. Gattex is an analog of glucagon-like peptide-2 (GLP-2). Earlier this year, FDA denied the company's request for Priority Review. ...