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23-Jan-2019

Novo Nordisk UK launches Ozempic® (semaglutide), a new once-weekly GLP-1 RA for adults with type 2 diabetes

 

 

Embargoed until 00:01 Wednesday 23 January 2019

press release 

Novo Nordisk UK launches Ozempic®    (semaglutide), a new once-weekly GLP-1 RA for adults with type 2 diabetes


Gatwick, 23 January 2019

 

Today, Novo Nordisk UK announces that Ozempic® (semaglutide), a new once-weekly GLP-1 analogue injection1 for the treatment of type 2 diabetes is now available in the UK.

 

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.

 

Cardiovascular disease is the number one cause of death and disability2 in type 2 diabetes worldwide. Leading charity Diabetes UK recently warned that people with type 2 diabetes are up to twice more likely to die prematurely from avoidable complications than those without the condition3. In the latest data available from NHS Digital (2016/17) 33% of people living with type 2 diabetes did not meet their blood glucose (HbA1c) target of ≤7.5%4. Alongside this 9 out of 10 are overweight or obese5.

 

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

 

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 said: “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. 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 1 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

 

Dr Avideh Nazeri, Director of Clinical, Medical and Regulatory for Novo Nordisk UK said: “When Type 2 diabetes is well managed, the risk of life-changing and life-limiting complications can be reduced1. 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

 

                                              -Ends-

 

 

About Ozempic® (semaglutide)1

Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1.

 

Semaglutide reduces blood glucose in a glucose dependent manner by stimulating insulin secretion and lowering glucagon secretion when blood glucose is high. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase. During hypoglycaemia, semaglutide diminishes insulin secretion and does not impair glucagon secretion.

 

Semaglutide reduces body weight and body fat mass through lowered energy intake, involving an overall reduced appetite. In addition, semaglutide reduces the preference for high fat foods.

 

Semaglutide also had a beneficial effect on plasma lipids and lowered systolic blood pressure in clinical studies.

 

About the studies6,7

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/

 

About Novo Nordisk

 

Novo Nordisk is a global healthcare company with 95 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people with obesity, haemophilia, growth disorders and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs approximately 43,200 people in 79 countries and markets its products in more than 170 countries.

 

 

Further information

 

Samantha Rowlands       +44 (0) 1293 613555          srow@novonordisk.com 

Natalie Lanyon   +44 (0)1625 664094            natalie.lanyon@thisispegasus.co.uk 

 

 

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.

 

Job ref: UK19OZMOO28

Date of prep: January 2019

 

Novo Nordisk Ltd

Corporate Communications

3 City Place Beehive Ring Road Gatwick West Sussex RH6 0PA

     Telephone:

     +44 1293 613555

Internet:

www.novonordisk.co.uk

 

Editor Details

  • Company:
    • Novo Nordisk
  • Name:
    • Samantha Rowlands
Last Updated: 23-Jan-2019