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Novo Nordisk Files for US FDA Approval of Oral Semaglutide for Blood Sugar Control and Cardiovascular Risk Reduction in Adults with Type 2 Diabetes

PLAINSBORO, N.J., March 20, 2019 /PRNewswire/ -- Novo Nordisk today announced the submission of two New Drug Applications (NDAs) to the US Food and Drug Administration (FDA) for oral semaglutide, the first once-daily glucagon-like peptide-1 (GLP-1) receptor agonist in a pill. One NDA was submitted seeking approval as an adjunct to diet and exercise to improve blood sugar in adults with type 2 diabetes. Novo Nordisk has submitted a priority review voucher (PRV) for this NDA with an anticipated review time of six months. The second NDA for oral semaglutide seeks approval for an indication to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or death in adults with type 2 diabetes and established cardiovascular disease (CVD) and has an anticipated 10-month review time.

Additionally, Novo Nordisk filed a supplemental NDA (sNDA) for once-weekly Ozempic® (semaglutide) injection 0.5 mg or 1 mg. The company is pursuing an indication to reduce the risk of MACE such as heart attack, stroke, or death in adults with type 2 diabetes and established CVD. The Ozempic® sNDA has an anticipated 10-month review time. Ozempic® was FDA approved on Dec 5, 2017 for adults with type 2 diabetes that along with diet and exercise may improve blood sugar.

"We are very excited about these three regulatory filings with the FDA as they represent a significant milestone for the company, but most importantly represent new potential treatment options for adults living with type 2 diabetes," said Todd Hobbs, vice president and US chief medical officer of Novo Nordisk. "We know that many adults with type 2 diabetes are still struggling to control their blood sugar and are at increased cardiovascular risk. We hope that, if approved, these products can help those patients."

The efficacy and safety of oral semaglutide was evaluated in 10 PIONEER clinical trials, which included 9,543 adults with type 2 diabetes. In the PIONEER program, people treated with oral semaglutide were compared to those taking sitagliptin, empagliflozin, liraglutide, and placebo.

The applications for the oral semaglutide and Ozempic® cardiovascular risk reduction indications are based on the results of two cardiovascular outcomes trials (CVOTs) examining the effects of adding semaglutide or placebo to standard of care on the risk of MACE in adults with type 2 diabetes and established CVD; PIONEER 6 with oral semaglutide and SUSTAIN 6 with Ozempic®.

About the PIONEER clinical trial program                                            
PIONEER is a global clinical trial program for oral semaglutide that comprises 10 Phase 3a clinical trials including a CVOT, involving 9,543 adults with type 2 diabetes.

About PIONEER 6 and SUSTAIN 6                                                          
PIONEER 6 was an event-driven, pre-approval CVOT for oral semaglutide. It was a randomized, double-blinded, placebo-controlled trial evaluating the cardiovascular safety of oral semaglutide vs placebo when added to standard of care in 3,183 adults with type 2 diabetes with established CVD or high risk of cardiovascular events.

SUSTAIN 6 was an event- and time-driven, pre-approval CVOT for Ozempic®. It was a randomized, double-blinded, placebo-controlled trial evaluating the cardiovascular safety of Ozempic® vs placebo when added to standard of care in 3,297 adults with type 2 diabetes with established CVD or high risk of cardiovascular events.

About Ozempic®
Ozempic® (semaglutide) injection 0.5 mg or 1 mg is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.1 Ozempic® was approved by the US Food and Drug Administration on December 5, 2017, by Health Canada on January 4, 2018, by the European Commission on February 9, 2018, by the Japanese Ministry of Health, Labour and Welfare on March 23, 2018, by Swissmedic on July 2, 2018, and by the Brazilian National Health Surveillance Agency on August 6, 2018.2-7

About the SUSTAIN clinical trial program
The SUSTAIN clinical development program for Ozempic® comprises 10 Phase 3 global clinical trials, including a CVOT, which included adults with type 2 diabetes with established CVD or high risk of cardiovascular events. The program involves more than 8,700 adults with type 2 diabetes in total (includes people from SUSTAIN 1-7 and 9).

About Novo Nordisk

Novo Nordisk is a global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for 95 years. This heritage has given us experience and capabilities that also enable us to help people defeat other serious diseases including obesity, hemophilia and growth disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term and do business in a financially, socially and environmentally responsible way. With U.S. headquarters in New Jersey and production and research facilities in four states, Novo Nordisk employs approximately 5,000 people throughout the country. For more information, visit novonordisk.us, Facebook and Twitter.

SOURCE Novo Nordisk

Posted: March 2019

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