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Product launch

Novo Nordisk launches semaglutide once-weekly GLP-1 RA for T2DM

The EU licensing of Ozempic is based on results from the SUSTAIN clinical trial programme

Novo Nordisk UK has announced that Ozempic (semaglutide), a once-weekly GLP-1 analogue injection1 for the treatment of type 2 diabetes is now available in the UK. According to the company, Ozempic works by mimicking the function of the GLP-1 (human glucagon-like peptide-1) hormone produced in the gut that lowers post-meal blood glucose levels and also slows glucose absorption into the bloodstream. Ozempic should be used alongside diet and exercise, as monotherapy when metformin is considered inappropriate due to intolerance or contraindications or in addition to other medicinal products for the treatment of diabetes, when type 2 diabetes is insufficiently controlled.

The EU licensing of Ozempic is based on results from the SUSTAIN clinical trial programme which consistently demonstrated:

  • superior glycaemic control compared to dulaglutide, exenatide once weekly, sitagliptin and insulin glargine U1006
  • superior and sustained weight loss compared to dulaglutide, exenatide once weekly, sitagliptin and insulin glargine U1006
  • cardiovascular benefits vs placebo both in addition to standard of care in people with type 2 diabetes at high risk for CV events7

“We know that people with uncontrolled type 2 diabetes are at risk of serious complications and that can have a real impact on their lives,” said Steve Bain, Professor of Medicine (Diabetes) at Swansea University and Assistant Medical Director for Research & Development for ABM University Health Board and Clinical Lead for the Diabetes Research Network, Wales. “Being able to offer medicines such as Ozempic®, which patients only need to take once a week, is an important step in helping to control the condition and reducing those risks.”

There are currently over 4 million people in the UK living with diabetes8 and with one in every 11 people in England now at risk of developing the condition, diabetes is the fastest-growing health threat facing the country.9,10  Type 2 diabetes costs the NHS £8.8bn a year, with 80% of that used to treat avoidable complications11. The cost of Ozempic® is £2.62 per day, so can be prescribed at no additional cost compared to other once-weekly GLP-1 RAs available.12,13

“When Type 2 diabetes is well managed, the risk of life-changing and life-limiting complications can be reduced1,” said Dr Avideh Nazeri, Director of Clinical, Medical and Regulatory for Novo Nordisk UK. “Novo Nordisk is proud to bring Ozempic to people living with type 2 diabetes in the UK. We believe the clinical profile of Ozempic will help to meet the real and serious needs of those living with this condition.”

Ozempic has received positive recommendation by the two UK health technology assessment (HTA) bodies, All Wales Medicines Strategy Group (AWMSG) and Scottish Medicines Consortium (SMC). Ozempic is recommended as a treatment option for restricted use within NHS Wales and NHS Scotland in the treatment of insufficiently controlled type 2 diabetes mellitus in adults as an add-on therapy to oral antidiabetic medicines or basal insulin.

Ozempic is available in 0.25mg as the starting dose that patients will take once a week for four weeks. Patients will then move up to 0.5mg once a week. After at least four weeks this dose can be increased to 1.0mg once-weekly to further improve glycaemic control if necessary.1

† Assumes 365.25 days per year. One semaglutide pen contains 4 x once weekly doses, (all doses, including needles) costs £73.25, for a daily cost of £2.6212,13

About the studies (6,7)

The licence of Ozempic® is based on the SUSTAIN clinical trial programme, a global clinical development programme that comprised eight phase 3a trials, encompassing more than 8,000 adults with type 2 diabetes. The phase 3a programme involved a broad range of people with type 2 diabetes, including some with high cardiovascular risk profiles and people with and without renal disease. Ozempic® was approved in EU on 9 Feb 2018.

About the recommendations

The detailed All Wales Medicines Strategy Group (AWMSG) and Scottish Medicines Consortium (SMC) recommendation/advice can be found here:

http://www.awmsg.org/awmsgonline/app/appraisalinfo/1842    

https://www.scottishmedicines.org.uk/medicines-advice/semaglutide-ozempic-fullsubmission-smc2092/

References

  1. Ozempic® [Summary of Product Characteristics]. Bagsvard, Denmark: Novo Nordisk A/S; 2018
  2. NHS Digital. (2018). National Diabetes Audit, 2016-17 Report 1: Care Processes and Treatment Targets. Available at: https://files.digital.nhs.uk/pdf/s/k/national_diabetes_audit_2016-17_report_1__care_processes_and_treatment_targets.pdf (last accessed, January 2019)
  3. Public Health England 2014. Adult obesity and type 2 diabetes. Available at: https://assets.publishing.service. gov.uk/government/uploads/system/uploads/attachment_data/file/338934/Adult_obesity_and_type_2_diabetes_.pdf. (last accessed, January 2019)
  4. Low Wang CC, Hess CN, Hiatt WR, et al. 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
  5. Diabetes UK. (2018). 500 people with diabetes die prematurely every week. Available: https://www.diabetes.org.uk/about_us/news/premature-deaths-diabetes (last accessed, January 2019)
  6. Pratley RE, Aroda VR, Lingvay I, et al. Ozempic® vs dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol. 2018;6(4) 275–286.
  7. Marso SP, Bain SC, Consoli A, et al. Ozempic® and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med. 2016;375:1834–1844.
  8. Diabetes UK. (2018) Number of people living with diabetes doubles in twenty years. Available: https://www.diabetes.org.uk/about_us/news/diabetes-prevalence-statistics (last accessed, January 2019)
  9. Diabetes UK. State of the Nation 2016 https://www.diabetes.org.uk/professionals/position-statements-reports/statistics/state-of-the-nation-2016-time-to-take-control-of-diabetes Last accessed July 2018 (last accessed, January 2019)
  10. Office of National Statistics, Population Estimates https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates (last accessed, January 2019)
  11. Diabetes UK. (2014). The Cost of Diabetes. Available at: www.diabetes.org.uk/resources-s3/2017-11/diabetes%20uk%20cost%20of%20diabetes%20report.pdf  (last accessed, January 2019)
  12. Novo Nordisk. Guidelines in practice. Type 2 diabetes Formulary decision guide: Ozempic® (semaglutide). November 2018.
  13. Novo Nordisk UK. Ozempic® prescribing information. July 2018.

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