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

BAGSVAERD, Denmark I October 18, 2017 I Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) voted 16-0 in favour of the approval of once-weekly semaglutide to improve glycaemic control in adults with type 2 diabetes. One member of the committee abstained. 

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 3a 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.

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.

Conference call

On 19 October 2017 at 8.00 am CEST (2.00 am EDT), Novo Nordisk will host a conference call for investors. Investors will be able to listen in via a link on the investor section of novonordisk.com/investors.

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.

SOURCE: Novo Nordisk

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