Napp to co-promote Invokana▼® (canagliflozin) for type 2 diabetes mellitus (T2DM)
Cambridge UK: Wednesday 8th June 2016 – Napp Pharmaceuticals Limited has announced that it has entered into a long-term partnership with Janssen Cilag Ltd to co-promote Invokana® (canagliflozin), a once-daily oral treatment for patients with T2DM in the UK.
Canagliflozin is indicated for the treatment of adult patients with T2DM, either as monotherapy or add-on therapy, to improve glycaemic control where diet and exercise do not provide adequate glycaemic control, or the use of metformin (another T2DM treatment) is contraindicated or not suitable.1
“We are delighted to have entered this long-term partnership with Janssen which builds upon and recognises Napp’s NHS and primary care expertise,” said Alberto Martinez, Managing Director, Napp Pharmaceuticals Limited. “We believe that canagliflozin is an important option for patients living with type 2 diabetes and we are looking forward to working with Janssen to support the NHS as it tackles one of the major challenges to health and well-being in the UK.”
Notes to editors:
About Invokana® (canagliflozin)
Invokana® (canagliflozin) is a member of a class of drugs known as sodium glucose co-transporter 2 (SGLT2) inhibitors.
SGLT2 inhibitors contribute to controlling blood glucose levels via the kidney. As glucose is filtered from the blood into the kidneys, it is reabsorbed back into the bloodstream. An important transport carrier in the renal proximal tubule responsible for this reabsorption is called sodium glucose co-transporter 2 (SGLT2). 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. This mechanism of action is independent of insulin.1
In November 2013, the European Commission approved Invokana® (canagliflozin) in the European Union for the treatment of adults with type 2 diabetes mellitus, to improve glycaemic control.
Canagliflozin has been studied as monotherapy and in combination with other type 2 diabetes therapies including insulin. The comprehensive global phase 3 clinical trial programme for canagliflozin enrolled 10,285 patients in nine studies and is one of the largest programmes for a pharmacological product for the treatment of type 2 diabetes.
The Phase 3 programme evaluated the safety and efficacy of canagliflozin across the spectrum of type 2 diabetes and included placebo and active comparator controlled studies. Three studies have compared canagliflozin to current standard treatments; two of which compared canagliflozin to sitagliptin which demonstrated a significant blood pressure reduction and a similar tolerability profile.2 A third study compared canagliflozin to glimepiride as dual therapy with metformin which showed a lower risk of hypoglycaemia.3 In all three comparator studies, canagliflozin 300mg provided greater and sustained reductions in HbA1C compared to those on placebo or an active comparator with the additional effect of significant weight reduction.
The Phase 3 programme also included two large studies in special populations: patients over age 55 with type 2 diabetes4 and patients with type 2 diabetes who were considered to be at high risk for cardiovascular disease.5
Adverse drug reactions related to the mode of action of SGLT2 inhibitors, and also associated with canagliflozin, include genital mycotic infections, urinary tract infections (UTIs), adverse events related directly to the osmotic diuresis (such as urinary frequency or thirst), and adverse events related to reduced intravascular volume (such as postural dizziness), as well as constipation, and a low incidence of rash or urticarial. Rare cases of diabetic ketoacidosis (DKA), including life-threatening cases, have been reported in clinical trials and post-marketing in patients treated with SGLT2 inhibitors, including canagliflozin.1
Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation.
About Napp Pharmaceuticals Limited
Napp Pharmaceuticals Limited is a privately owned UK organisation based in the heart of the Cambridge science community, and part of a worldwide network of independent 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, oncology and inflammatory disorders.
For more information, please visit http://napp.co.uk/.
About Type 2 Diabetes
Type 2 diabetes is a chronic condition that affects the body’s ability to metabolize sugar (glucose) and is characterized by the inability of beta cells in the pancreas to keep up with the body’s demand for insulin. In most people with type 2 diabetes, obesity causes resistance to the action of insulin and if the pancreatic beta cells cannot produce enough insulin, high blood sugar levels (hyperglycemia) and type 2 diabetes ensue.
If left uncontrolled, type 2 diabetes can lead to serious long-term complications such as macrovascular disease (myocardial infarctions, strokes, peripheral vascular disease) and microvascular disease including nerve disease leading to amputation, retinopathy resulting in blindness and nephropathy causing end-stage renal disease.
- INVOKANA SmPC. Available at http://www.medicines.org.uk/emc/medicine/28400 [Accessed: June 2016]
- Schernthaner G et al. Canagliflozin compared with sitagliptin for patients with type 2 diabetes who do not have adequate glycemic control with metformin plus sulfonylurea: a 52-week randomized trial. Diabetes Care. 2013; 36(9):2508-15
- Cefalu WT et al. 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. 2013; 382(9896):941-50.
- Bode B et al. Efficacy and safety of canagliflozin treatment in older subjects with type 2 diabetes mellitus: a randomized trial. Hosp Pract. 2013;41(2):72-84.
- Neal B, Perkovic V, et al. (2013). Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)—A randomized placebo-controlled trial. American Heart Journal; 166(2): 217-223
June 2016 UK/CORP-16021