BRIEF -- FDA briefs ahead of semaglutide advisory review

Novo Nordisk today announced that the US Food and Drug Administration 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 October 18, 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 program 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:

https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials