Will Novo Nordisk's semaglutide be its next blockbuster?

Semaglutide receives positive 16-0 vote in favour of approval from FDA Advisory Committee.

Based on the data included in the New Drug Application (NDA) for semaglutide, the FDA asked the panel members to discuss whether Novo Nordisk has provided adequate evidence to establish the efficacy and safety profile of semaglutide for the treatment of type 2 diabetes in adults.

The recommendation for approval was based on a global development programme involving more than 8,000 adults with type 2 diabetes in the eight SUSTAIN Phase IIIa clinical trials, including a cardiovascular outcomes trial.

"Semaglutide has demonstrated the potential to improve the treatment of type 2 diabetes and the positive recommendation from the Advisory Committee marks an important step towards making semaglutide available to adults with type 2 diabetes in the US. We look forward to working with the FDA as they complete their review of semaglutide," said Mads Krogsgaard Thomsen, executive vice president and chief science officer.

In addition, more people treated with once-weekly semaglutide achieved reductions in both glucose and weight vs. comparator treatments.

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.