FDA Approves Ozempic (semaglutide) for
`Cardiovascular Risk Reduction in Adults with Type 2
`Diabetes and Known Heart Disease
`PLAINSBORO, N.J., Jan. 16, 2020 /PRNewswire/ -- Novo Nordisk today announced that the U.S. Food
`and Drug Administration (FDA) has approved a new indication for Ozempic (semaglutide) injection 0.5
`mg or 1 mg to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack,
`1
`stroke, or death in adults with type 2 diabetes and known heart disease. Additional details were added
`to the Rybelsus (semaglutide) tablets 7 mg or 14 mg Prescribing Information about the primary analysis
`for PIONEER 6.
`
`Cardiovascular disease (CVD) is the main cause of death and disability among people with type 2
`2
`diabetes. Adults with type 2 diabetes are two to four times more likely to develop CVD than adults
`3
`without diabetes.
`
`The FDA's decision on Ozempic is based on results from the SUSTAIN 6 cardiovascular outcomes trial
`(CVOT) which examined the cardiovascular safety of adding Ozempic or placebo to standard of care in
`adults with type 2 diabetes and established cardiovascular disease. In the 2-year SUSTAIN 6 trial,
`Ozempic significantly reduced the risk of the occurrence of a three-component MACE endpoint
`consisting of cardiovascular death, non-fatal heart attack or non-fatal stroke. The estimated relative risk
`reduction of MACE was 26% vs placebo (HR 0.74 [95% CI: 0.58, 0.95], p<0.001 for noninferiority,
`median observation time 2.1 years) with the primary composite outcome occurring in 6.6% of patients
`treated with Ozempic® vs 8.9% with placebo.1,4 During the trial, gastrointestinal adverse events were
`more frequent in the Ozempic® group than in the placebo group. The majority of gastrointestinal adverse
`4
`events occurred during the first 30 weeks.
`
`"There is a well-established link between cardiovascular disease and type 2 diabetes. It's one of our
`biggest concerns with type 2 diabetes because even when patients reach their blood sugar targets, the
`risk of a major adverse CV event remains," said Todd Hobbs, vice president and U.S. chief medical
`officer of Novo Nordisk. "Today's milestone establishes Ozempic® as an option for patients to help
`address two critical aspects of managing type 2 diabetes, blood sugar control and cardiovascular risk
`reduction, in those with known heart disease."
`
`The Rybelsus prescribing information has been updated in section 14 (clinical studies) to include an
`analysis from the primary endpoint of the PIONEER 6 CVOT showing the hazard ratio for time to first
`5
`three-component MACE (HR 0.79 [95% CI: 0.57, 1.11]).
`
`Novo Nordisk Exhibit 2481
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`

`

`In June 2019, Novo Nordisk initiated the SOUL CVOT in 9,642 adults with type 2 diabetes and
`established cardiovascular disease to further evaluate the cardiovascular effect of Rybelsus. The trial is
`investigating the effects of Rybelsus on the incidence of MACE vs placebo in addition to standard of
`care.
`About the SUSTAIN 6 Trial
`SUSTAIN 6 was an event- and time-driven, pre-approval CVOT for Ozempic®. It was a randomized,
`double-blinded, noninferiority 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 for
`a minimum observation period of two years.
`About Ozempic
`Ozempic (semaglutide) injection 0.5 mg or 1 mg is a once-weekly glucagon-like peptide-1 (GLP-1)
`receptor agonist indicated along with diet and exercise to improve blood sugar (glucose) in adults with
`type 2 diabetes mellitus and to reduce the risk of major cardiovascular events such as heart attack,
`stroke or death in adults with type 2 diabetes mellitus with known heart disease. Ozempic was approved
`by the U.S. 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.
`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 six
`states, Novo Nordisk employs nearly 6,000 people throughout the country. For more information, visit
`novonordisk.us, Facebook, Instagram and Twitter.
`
`References
`
`1. Ozempic® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; January 2020.
`
`2. Low Wang CC, Hess CN, Hiatt WR, Goldfine AB. Clinical Update: Cardiovascular disease in
`diabetes mellitus: Atherosclerotic cardiovascular disease and heart failure in type 2 diabetes mellitus
`- mechanisms, Management, and Clinical Considerations. Circulation. 2016;133(24):2459-2502.
`
`Novo Nordisk Exhibit 2481
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`

`

`3. World Heart Federation. Cardiovascular disease risk factors. Available at: www.world-heart-
`federation.org/cardiovascular-health/cardiovascular-disease-risk-factors/diabetes/. Accessed
`January 9, 2020.
`
`4. Marso SP, Bain SC, Consoli A, et al; SUSTAIN-6 Investigators. Semaglutide and cardiovascular
`outcomes in patients with type 2 diabetes. N Engl J Med. 2016:375:1834-1844.
`
`5. Rybelsus® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; January 2020.
`
`SOURCE Novo Nordisk
`
`Posted: January 2020
`
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`Ozempic (semaglutide) FDA Approval History
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`Novo Nordisk Exhibit 2481
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
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`Novo Nordisk Exhibit 2481
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
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