Novo Nordisk: FDA posts briefing materials prior to Advisory Committee meeting for semaglutide

Bagsvaerd, DENMARK

Bagsværd, Denmark, 16 October 2017 - Novo Nordisk today announced that the US Food and Drug Administration (FDA) has published the briefing documents ahead of the Advisory Committee meeting to discuss the New Drug Application (NDA) for approval of semaglutide, a once-weekly analogue of human glucagon-like peptide-1 (GLP-1) for the treatment of type 2 diabetes in adults.

The meeting takes place on 18 October 2017. The briefing documents from Novo Nordisk and the FDA form the basis for the Advisory Committee's discussion, and provide 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 briefing materials can be accessed on the FDA webpage

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.

About advisory committees

FDA advisory committees are panels of independent experts who advise the FDA on specific questions raised by the FDA as they consider regulatory decisions. The FDA is not bound by the committee's recommendation, but it takes its advice into consideration when reviewing data concerning the safety and efficacy of marketed drugs or new drug applications.

Further information

Anne Margrethe Hauge +45 3079 3450
Ken Inchausti (US) +1 609 786 8316
Peter Hugreffe Ankersen +45 3075 9085
Hanna Ögren +45 3079 8519
Anders Mikkelsen +45 3079 4461
Christina Kjær +45 3079 3009
Kasper Veje (US) +1 609 235 8567

Company announcement No 79 / 2017