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October 19, 2017
Novo Nordisk Pharmatech A/S

Novo Nordisk receives positive 16-0 vote from FDA Advisory Committee in favor of approval for semaglutide

Peter Hartman spoke to Rapidus about investment promotion and the new joint microbiome project with Copenhagen Capacity and Invbest in Skåne.

Novo Nordisk receives positive 16-0 vote from FDA Advisory Committee in favor of approval for semaglutide

PLAINSBORO, N.J., Oct. 18, 2017 /PRNewswire/ -- Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) voted 16-0, supporting the approval of once-weekly semaglutide to improve glycemic control in adults with type 2 diabetes. One member of the committee abstained.

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

The recommendation for approval was based on data from SUSTAIN, a comprehensive global development program that evaluated the safety and efficacy of semaglutide, administered once-weekly. The global SUSTAIN Phase 3a clinical trial program comprised eight clinical trials (one of which was a 2-year cardiovascular outcomes trial), involving more than 8,000 adults with type 2 diabetes, including adults with high cardiovascular risk profiles, with and without renal disease.

"Semaglutide has the potential to impact the lives of people with type 2 diabetes by helping to meaningfully reduce A1c. This treatment option may also help people lose weight," said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk. "We look forward to continuing to work with the FDA as they complete their review of semaglutide."

The NDA for once-weekly semaglutide was submitted to the FDA in December 2016 under the U.S. FDA's Prescription Drug User Fee Act V (PDUFA V) regulation. Semaglutide is currently also under review by 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.

About semaglutide
Semaglutide is an investigational analog of native human glucagon-like peptide-1 (GLP-1) and, through its high albumin binding resulting in a long half-life of approximately one week, semaglutide is suitable for once-weekly dosing. Like other GLP-1 receptor agonists (GLP-1 RAs), semaglutide, administered once-weekly, stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner.

About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: hemophilia, growth disorders and obesity. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has nearly 5,000 employees in the United States. For more information, visit novonordisk.us or follow us on Twitter: @novonordiskus.

Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2017 Novo Nordisk All rights reserved. USA17SEM02889 October 2017

SOURCE Novo Nordisk

For further information: Media: Ken Inchausti (U.S.), +1 267 809 7552, kiau@novonordisk.com;
Ambre Brown Morley (U.S.), +1 609 216 5240, abmo@novonordisk.com;
Christopher Clark (U.S.), +1 609 619 1831, cpcr@novonordisk.com;
Investors: Peter Hugreffe Ankersen, +45 3075 9085, phak@novonordisk.com;
Hanna Ögren, +45 3075 8519, haoe@novonordisk.com;
Anders Mikkelsen, +45 3079 4461, armk@novonordisk.com;
Kasper Veje (U.S.), +1 609 235 8567, kpvj@novonordisk.com

Last updated:
October 19, 2017

Novo Nordisk Pharmatech A/S

Novo Nordisk Pharmatech is a leading global supplier of high-quality ingredients for the biopharmaceutical and pharmaceutical industries. By delivering excellence at every step of the supply chain, we help our customers keep products supplied to hospitals and patients. Improving lives every day.

Click here to read more about us!

PLAINSBORO, N.J., Oct. 18, 2017 /PRNewswire/ -- Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) voted 16-0, supporting the approval of once-weekly semaglutide to improve glycemic control in adults with type 2 diabetes. One member of the committee abstained.

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

The recommendation for approval was based on data from SUSTAIN, a comprehensive global development program that evaluated the safety and efficacy of semaglutide, administered once-weekly. The global SUSTAIN Phase 3a clinical trial program comprised eight clinical trials (one of which was a 2-year cardiovascular outcomes trial), involving more than 8,000 adults with type 2 diabetes, including adults with high cardiovascular risk profiles, with and without renal disease.

"Semaglutide has the potential to impact the lives of people with type 2 diabetes by helping to meaningfully reduce A1c. This treatment option may also help people lose weight," said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk. "We look forward to continuing to work with the FDA as they complete their review of semaglutide."

The NDA for once-weekly semaglutide was submitted to the FDA in December 2016 under the U.S. FDA's Prescription Drug User Fee Act V (PDUFA V) regulation. Semaglutide is currently also under review by 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.

About semaglutide
Semaglutide is an investigational analog of native human glucagon-like peptide-1 (GLP-1) and, through its high albumin binding resulting in a long half-life of approximately one week, semaglutide is suitable for once-weekly dosing. Like other GLP-1 receptor agonists (GLP-1 RAs), semaglutide, administered once-weekly, stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner.

About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: hemophilia, growth disorders and obesity. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has nearly 5,000 employees in the United States. For more information, visit novonordisk.us or follow us on Twitter: @novonordiskus.

Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2017 Novo Nordisk All rights reserved. USA17SEM02889 October 2017

SOURCE Novo Nordisk

For further information: Media: Ken Inchausti (U.S.), +1 267 809 7552, kiau@novonordisk.com;
Ambre Brown Morley (U.S.), +1 609 216 5240, abmo@novonordisk.com;
Christopher Clark (U.S.), +1 609 619 1831, cpcr@novonordisk.com;
Investors: Peter Hugreffe Ankersen, +45 3075 9085, phak@novonordisk.com;
Hanna Ögren, +45 3075 8519, haoe@novonordisk.com;
Anders Mikkelsen, +45 3079 4461, armk@novonordisk.com;
Kasper Veje (U.S.), +1 609 235 8567, kpvj@novonordisk.com

Last updated:
October 19, 2017

Novo Nordisk Pharmatech A/S

Novo Nordisk Pharmatech is a leading global supplier of high-quality ingredients for the biopharmaceutical and pharmaceutical industries. By delivering excellence at every step of the supply chain, we help our customers keep products supplied to hospitals and patients. Improving lives every day.

Click here to read more about us!