The US Food and Drug Administration (FDA) has published the briefing documents ahead of the Advisory Committee meeting to discuss the Novo Nordisk’s  New Drug Application (NDA) for approval of semaglutide,  for the treatment of type 2 diabetes in adults.

The meeting is scheduled for Wednesday, and should give an overview of the global development programme for semaglutide, including data from the SUSTAIN 3a clinical trial programme, which enrolled more than 8,000 adults with type 2 diabetes.

The NDA for once-weekly semaglutide was submitted to the FDA in December 2016 under the US FDA’s Prescription Drug User Fee Act V (PDUFA V) regulation. Semaglutide is currently under review by several regulatory agencies, including the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.