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INVOKANA® (canagliflozin) and VOKANAMET® (canagliflozin and metformin) labelling now approved to include positive cardiovascular and renal outcomes from the CANVAS programme which show a reduction in morbidity and mortality [1,2,3]
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In 2017, Janssen appointed Napp Pharmaceuticals Ltd as its exclusive distributor for both Invokana® and Vokanamet® in the UK, where both products are available on the NHS[4,5]
Cambridge, UK: 7 September 2018 – As the UK distributor of Invokana® (canagliflozin) and Vokanamet® (canagliflozin and metformin) Napp welcomes the announcement from the Janssen Pharmaceutical Companies of Johnson & Johnson that the European Commission (EC) has granted approval to update the Invokana® (canagliflozin) and Vokanamet® (canagliflozin and metformin) labels to include changes to the indication statement for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.[1,2]
The approved product information now includes additional results from the CANVAS programme, specifically a reduction in the relative risk of major adverse cardiovascular events by 14%, hospitalisation for heart failure by 33%. In addition, there were renal benefits, seen as a reduction in the doubling of serum creatinine, the need for renal replacement therapy and renal death by 47% and the progression of albuminuria by 27% in people with type 2 diabetes and either a history of cardiovascular disease or at least two cardiovascular risk factors.[3]
Commenting on the news, Professor Richard Donnelly, Professor in Medicine at The University of Nottingham said, “this change in the licence for canagliflozin will be welcomed by clinicians and GPs. We can now have full confidence to prescribe canagliflozin not only as a glucose-lowering agent, but as a treatment for type 2 diabetes that also confers a substantial reduction in the risk of life-threatening cardiovascular complications in those high-risk patients who already have established cardiovascular disease or multiple cardiovascular risk factors.”
“We hope this approval will not only provide clinicians with a more detailed overview of canagliflozin but also help them when making informed treatment decisions which are most appropriate for their patients. Type 2 diabetes mellitus is the most common form of diabetes in the UK, so it is extremely important that we continue improving outcomes for these patients,” said Paul Schofield, Medical Director at Napp.
The EC’s decision follows a recommendation from the Committee for Medical Products for Human Use (CHMP) that was based on data from the CANVAS programme, the largest completed cardiovascular outcomes trial to date for an SGLT2 inhibitor.[3]
Canagliflozin was approved in the European Union by the European Commission in November 2013 and is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus.[1,2] Approval was based on a comprehensive global Phase 3 clinical trial programme.[3]
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Notes to editors:
About the CANVAS programme
The CANVAS programme (N=10,142) comprises the two large canagliflozin cardiovascular outcome studies, CANVAS and CANVAS-R, and includes a pre-specified integrated analysis of these two studies to evaluate the potential for cardiovascular protection of canagliflozin in patients with type 2 diabetes mellitus who had either a prior history of cardiovascular disease or at least two cardiovascular risk factors. The integrated analysis also evaluated the effects of canagliflozin on renal and safety outcomes.[3]
Canagliflozin met the primary outcome by significantly reducing the rates of the composite of major adverse cardiovascular events (MACE) comprised of cardiovascular mortality, non-fatal myocardial infarction (MI), or non-fatal stroke (26.9 vs. 31.5/1000 patient-years, hazard ratio (HR) 0.86; 95% confidence interval (CI 0.75-0.97; P<0.0001 for noninferiority; P=0.0158 for superiority) compared with placebo, respectively.[3] All 3 components of the MACE composite (cardiovascular death, non-fatal MI, and non-fatal stroke) exhibited point estimates of effect suggesting benefit with canagliflozin.[3]
Adverse events reported in the CANVAS programme were generally consistent with the known safety profile of canagliflozin.[3] However, the study found that, in patients with type 2 diabetes who had established cardiovascular disease or at least two risk factors for cardiovascular disease, canagliflozin was associated with an approximately 2-fold increased risk of lower limb amputation with the rate of amputation over standard of care being 0.63/100 patient years for canagliflozin versus 0.34/100 patient years for placebo which corresponds to an additional risk of 0.29/100 patient years.[3] The risk of amputations across the class has previously been investigated by the EMA, and this is reflected in a warning in the labelling of all SGLT2 inhibitors.
About Invokana (canagliflozin)
Invokana is a member of a class of drugs known as sodium glucose co-transporter 2 (SGLT2) inhibitors.[7]
SGLT2 inhibitors contribute to controlling blood glucose levels via the kidney.[7,8] As glucose is filtered from the blood into the kidneys, it is reabsorbed back into the bloodstream.[8,9] SGLT2is are an important transport carrier in the kidneys for this reabsorption.[7] Canagliflozin selectively inhibits SGLT2, and, as a result, promotes the loss of glucose via the urine, lowering blood glucose levels in adults with type 2 diabetes.[8,10] This mechanism of action is independent of insulin.[1] In November 2013, the European Commission approved canagliflozin in the European Union for the treatment of adults with type 2 diabetes to improve glycaemic (i.e blood sugar) control.[8]
Invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.[1] Approval was based on a comprehensive global Phase 3 clinical trial programme.
About Vokanamet (canagliflozin and metformin)
Vokanamet is approved in the European Union to improve glycaemic control of adult patients with type 2 diabetes as an adjunct to diet and exercise and combines two oral glucose-lowering medicinal products with different and complementary mechanisms of action.[2]
About Type 2 Diabetes
Type 2 diabetes is a chronic condition that results in the body being unable to metabolise sugar (glucose).[11] A number of factors can increase the risk of developing type 2 diabetes, including obesity.[11,12] Obesity, specifically excess abdominal fat, can make the body less sensitive to insulin, causing a resistance by disrupting the function of insulin responsive cells and therefore the cells’ ability to respond to insulin, leading to higher blood sugar levels (hyperglycemia).[11,12]
If left uncontrolled, type 2 diabetes can lead to long-term complications such as heart attack, stroke, kidney damage (nephropathy), eye disease (retinopathy) and peripheral nerve damage (neuropathy).[11]
About Napp Pharmaceuticals Limited
Napp Pharmaceuticals Limited is a UK pharmaceutical company based in the heart of the Cambridge science community, and part of a worldwide network of independently associated companies across 48 countries. Napp has grown up with the NHS, providing innovative medicines to patients in the UK since the 1920s. Napp is committed to improving patient outcomes and ensuring the sustainability of healthcare. At Napp, we are proud of our heritage, which began in the treatment of chronic pain and has expanded into respiratory medicine, diabetes, oncology and inflammatory disorders.
For more information, please visit: www.napp.co.uk
For further information, please contact:
Hanna Wikström, Communications Lead,
Napp Pharmaceuticals Ltd
T: +44 (0)1223 424 444
References
[1] EMC. 2018. SmPC. Invokana 100 mg and 300 mg film-coated tablets. Available at: https://www.medicines.org.uk/emc/product/8855#INDICATIONS. Last Accessed: September 2018.
[2] EMC. 2018. SmPC. Vokanamet 50 mg/850 mg film-coated tablets. Available at: https://www.medicines.org.uk/emc/product/3407/smpc. Last Accessed: September 2018.
[3] Neal B et al. 2017.Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. NEJM. 377:644-57.
[4] MIMS. 2018. Invokana. Available at: https://www.mims.co.uk/drugs/diabetes/oral-and-parenteral-hypoglycaemics/invokana. Last Accessed: September 2018.
[5] MIMS. 2018. Vokanamet. Available at: https://www.mims.co.uk/drugs/diabetes/oral-and-parenteral-hypoglycaemics/vokanamet. Last Accessed: September 2018.
[6] Diabetes UK. 2018. What is Type 2 diabetes? Available at: https://www.diabetes.org.uk/diabetes-the-basics/what-is-type-2-diabetes. Last accessed: September 2018.
[7] Diabetes.co.uk. 2017. Invokana (Canagliflozin). Available at: http://www.diabetes.co.uk/diabetes-medication/invokana-canagliflozin.html. Last Accessed: September 2018.
[8] European Medicines Agency. 2013. EPAR Summary for the Public: Invokana canagliflozin. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002649/WC500156455.pdf. Last Accessed: September 2018.
[9] Bays H. 2013. Sodium Glucose Co-transporter Type 2 (SGLT2) Inhibitors: Targeting the Kidney to Improve Glycemic Control in Diabetes Mellitus. Diabetes Therapy. 4(2): 195–220.
[10] Cefalu W T et al. 2013. Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. Lancet. 382 (9896):941-950.
[11] Diabetes.co.uk. 2018. Type 2 Diabetes. Available at: http://www.diabetes.co.uk/type2-diabetes.html Last Accessed: September 2018.
[12] Diabetes.co.uk. 2018. Diabetes and Obesity. Available at: http://www.diabetes.co.uk/type2-diabetes.html. Last Accessed: September 2018.
