FDA has approved a Takeda Pharmaceuticals supplemental NDA to expand the indication for Gattex’s (teduglutide) for injection to pediatric patients aged one year and older with short bowel syndrome who need additional nutrition or fluids from intravenous feeding (parenteral support). Approval was based on data from a 24-week pediatric study that demonstrated Gattex helped reduce the volume of daily parenteral support (PS) required and time spent administering PS, the company says. “Some children even achieved complete freedom from PS,” it adds.
Takeda says Gattex has a demonstrated safety profile that is similar overall in pediatric and adult patients. The most common adverse reactions seen in adult patients are abdominal pain, nausea, upper respiratory tract infection, abdominal distension, injection site reaction, vomiting, fluid overload, and hypersensitivity, it says.