• De goedkeuring van de Europese Commissie (EC) is gebaseerd op de Canagliflozin and Renal Endpoints in Diabetes with Established Nefropathy Clinical Evaluation (CREDENCE) Phase III renale resultaten studie, die vroegtijdig werd stopgezet na een geplande tussentijdse analyse op basis van het behalen van een vooraf gespecificeerde werkzaamheid criterium
• Canagliflozine is de eerste therapie die in bijna 20 jaar is goedgekeurd, sinds de goedkeuring van angiotensineconverterende enzym (ACE) -remmers en angiotensine II-receptorblokkers (ARB’s), om de progressie van diabetische nierziekte (DKD) te vertragen bij patiënten met diabetes mellitus type 2 (T2DM) in Europa, inclusief patiënten met matige en ernstige nierinsufficiëntie en albumuminurie (urinealbumine: creatinineverhouding> 300 mg / g) 1
• Naar schatting 59 miljoen volwassenen in Europa hebben diabetes, van wie ongeveer 90% T2DM heeft.2 Ongeveer 40% van de mensen met T2DM zal nierziekte ontwikkelen.3

CAMBRIDGE, Engeland – (BUSINESS WIRE) – ALLEEN STRIKT VOOR EUROPESE MEDISCHE EN FARMACEUTISCHE HANDELSMEDIA

Mundipharma kondigt vandaag aan dat de Europese Commissie (EC) de uitbreiding van de indicatie Invokana® (canagliflozine) heeft goedgekeurd om belangrijke renale uitkomstgegevens van de mijlpalen Canagliflozine en Renale Eindpunten in Diabetes op te nemen met een gevestigde Nefropathie Klinische Evaluatie (CREDENCE) studie. 1 Canagliflozin is nu de enige in Europa goedgekeurde natriumglucosetransporter 2-remmer (SGLT2i) met een uitgebreide indicatie voor de behandeling van diabetische nierziekte (DKD) bij patiënten met type 2 diabetes (T2DM).

European Commission approves extended Invokana® (canagliflozin) indication to reflect improved renal outcomes in patients with diabetic kidney disease and type 2 diabetes seen in CREDENCE study

• The European Commission (EC) approval is based on the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) Phase III renal outcomes trial, which was stopped early after a planned interim analysis based on the achievement of a pre-specified efficacy criterion
• Canagliflozin is the first therapy approved in nearly 20 years, since the approval of angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs), to slow the progression of diabetic kidney disease (DKD) in patients with type 2 diabetes mellitus (T2DM) in Europe, including patients with moderate and severe renal impairment and albuminuria (urinary albumin: creatinine ratio >300 mg/g)¹
• An estimated 59 million adults in Europe have diabetes, around 90% of whom have T2DM.² Approximately 40% of people with T2DM will go on to develop kidney disease.³

CAMBRIDGE, England–(BUSINESS WIRE)– STRICTLY FOR EUROPEAN MEDICAL AND PHARMACEUTICAL TRADE MEDIA ONLY

Mundipharma today announces that the European Commission (EC) has approved the extension of the indication of Invokana^® (canagliflozin) to include important renal outcome data from the landmark Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial.¹ Canagliflozin is now the only sodium glucose co-transporter 2 inhibitor (SGLT2i) approved in Europe with an extended indication to treat diabetic kidney disease (DKD) in type 2 diabetes (T2DM) patients.

For the first time in Europe, T2DM patients with an estimated glomerular filtration rate (eGFR) between 60 and 45 mL/min/1.73m² can now initiate treatment with canagliflozin 100mg. In addition, T2DM patients with albuminuria and an eGFR ≥30 mL/min/1.73m² can now start treatment with canagliflozin 100mg and continue until dialysis or renal transplantation.⁴

“We are delighted with this extended indication granted by the European Commission, which means that patients with T2DM and kidney complications now have a new treatment option to help reduce their risk of developing kidney failure, thus potentially reducing the need for dialysis or kidney transplantation.” said Dr Vinicius Gomes de Lima, European Medical Affairs Lead, Mundipharma. “The European Medicines Agency has reinforced that management of DKD should be a key treatment goal of type 2 diabetes and it is therefore crucial that physicians have effective treatments to help stop the progression of this life-threatening complication.”

Professor Vlado Perkovic, Study Author and Professorial Fellow at the George Institute, Australia, Dean of Medicine at UNSW Sydney commented: “Canagliflozin is the first medical breakthrough in nearly 20 years proven to slow the progression of chronic kidney disease in patients with diabetes at high risk of developing kidney failure. These impressive results from the CREDENCE study have significant clinical implications for preventing kidney failure and have now been incorporated in major kidney, diabetes and cardiovascular guidelines globally. They provide an opportunity to significantly improve the health of millions of people living with chronic kidney disease and type 2 diabetes. With the new approval by The European Commission, these benefits can be realised by people across Europe.”

The CREDENCE trial is the first dedicated renal outcomes study in patients with DKD and T2DM. The study enrolled 4401 subjects with an eGFR of 30 to <90ml/min/1.73m² and albuminuria (urinary albumin: creatinine ratio >300 to 5000 mg/g). Importantly, all patients were treated on a background of standard of care for DKD, including a maximum tolerated dose of an ACE inhibitor or ARB. The results showed that canagliflozin demonstrated a 30% reduction, compared to placebo, in the risk of the primary composite endpoint, comprising end-stage renal disease (ESRD), doubling of serum creatinine and renal or cardiovascular (CV) death, with event rates of 43.2 vs 61.2 per 1000 patient years, respectively (Hazard Ratio [HR]: 0.70; 95% Confidence Interval [CI]: 0.57 to 0.84; p<0.0001).⁵

Rates of adverse events and serious adverse events were similar overall in the canagliflozin group and the placebo group. There were no statistical differences in the incidence of lower limb amputations (canagliflozin 12.3 vs placebo 11.2 events per 1000 patient years; HR: 1.11; 95% CI: 0.79 to 1.56) or adjudicated bone fractures (canagliflozin 11.8 vs 12.1 events per 1000 patient years; HR: 0.98; 95% CI: 0.70 to 1.37).⁵ The study was stopped early in July 2018, owing to positive efficacy findings.

Canagliflozin has been approved in the European Union since 2013, where it is indicated for the treatment of adults with insufficiently controlled T2DM as an adjunct to diet and exercise, either as monotherapy or in addition to other blood sugar-reducing medicinal products.⁴ Please visit https://ec.europa.eu/health/documents/community-register/html/h884.htm for full prescribing information. As commercial partner to Janssen Pharmaceutica NV, Mundipharma has exclusive distribution rights for canagliflozin in various countries within Europe.

-END-

Notes to the editors:

About Invokana^® (canagliflozin)

Canagliflozin is an oral, once-daily medication that belongs to a class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors. SGLT2 inhibitors work by inhibiting SGLT2 co-transporter, which promotes the excretion of glucose via the urine, and thus helps lowering blood glucose levels in adults with T2DM.

Canagliflozin was approved in the European Union by the European Commission in November 2013. It is indicated for the treatment of adults with insufficiently controlled T2DM as an adjunct to diet and exercise, as monotherapy when metformin is considered inappropriate due to intolerance or contra-indications and in addition to other medicinal products for the treatment of diabetes.

The recommended initiation dose of canagliflozin is 100 mg once daily in adults with an eGFR of ≥ 60 mL/min/1.73 m² and can be increased to 300 mg once daily if tighter glycaemic control is needed. For patients with an eGFR of 45 to <60 mL/min/1.73 m² the initiation dose is limited to 100mg once daily, if further glycaemic control is needed the addition of other anti-hyperglycaemic agents should be considered. In patients with an eGFR of 30 to < 45 mL/min/1.73 m² with a urinary albumin/creatinine ratio ˃ 300 mg/g, the initiation dose is limited to 100 mg once daily, if further glycaemic control is needed the addition of other anti-hyperglycaemic agents should be considered. Canagliflozin should not be initiated if eGFR is below 30 mL/min/1.73 m², but for patients already taking canagliflozin it should be continued at 100 mg until dialysis or renal transplantation is required.⁴

Approval in November 2013 was based on a comprehensive global Phase III clinical trial programme.

About the CREDENCE Clinical Trial⁵

The CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) study was the first dedicated and fully recruited renal outcome trial evaluating renal and cardiovascular outcomes in people with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) with a sodium glucose co-transporter 2 (SGLT2) inhibitor. It was a phase III randomised, double-blind, event-driven, placebo-controlled, parallel-group, two-arm multicentre study of the effects of canagliflozin on renal and cardiovascular outcomes in subjects with T2DM and CKD. In particular, it compared the efficacy and safety of canagliflozin versus placebo in preventing clinically important kidney and cardiovascular outcomes in patients with T2DM and CKD when used in addition to standard of care, including a maximum tolerated daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB).

About the Mundipharma network

Mundipharma is a global network of privately-owned independent associated companies whose purpose is To Move Medicine Forward. With a high performing and learning organisation that strives for innovation and commercial excellence through partnerships, we have successfully transformed and diversified our European portfolio of medicines to create value for patients, healthcare professionals, payers and wider healthcare systems across important therapeutic areas such as Diabetes, Oncology, Biosimilars, Anti-Infectives and Respiratory.

Invokana^® is a registered trademark of Johnson & Johnson. The Marketing Authorisation Holder is Janssen-Cilag International NV.

References:

¹ European Commission. 26th June 2020 Decision C(2013)8171(final) for Invokana – canagliflozin. Available at https://ec.europa.eu/health/documents/community-register/html/h884.htm. Last accessed July 2020.

² International Diabetes Federation. IDF Diabetes Atlas – 9th Edition. Available at: https://www.diabetesatlas.org/en/resources/. Last accessed June 2020.

³Alicic R, Rooney M, Tuttle K. Diabetic Kidney Disease: Challenges, Progress, and Possibilities. Clin J Am Soc Nephrol. 2017; 12(12):2032-45.

⁴ Invokana summary of product characteristics. Updated June 2020. Available at https://ec.europa.eu/health/documents/community-register/html/h884.htm. Last accessed July 2020.

⁵ Perkovic, V. et al. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med. 2019; 380:2295–2306.

Job code: MINT/MINVK-20025

Date of preparation: July 2020

View source version on businesswire.com: https://www.businesswire.com/news/home/20200701005847/en/

Contacts

Cendrine Banerjee-Quetel
Asset Communications Associate, Mundipharma International Ltd
Email: Cendrine.Banerjee-Quetel.external@mundipharma.com
Tel: +44 1223 393 009

Abbie Bell
Account Director, Havas SO
Email: HavasSO-Mundipharma@havasso.com
Tel: +44 7375 660 515