Business Wire

MUNDIPHARMA

Share
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

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 (C anagliflozin and R enal E vents in D iabetes with E stablished N ephropathy C linical E valuation) 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.
3 Alicic 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

Link:

ClickThru

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Valeo Foods Group Acquires Melegatti Cakes Expanding the Italian Bakery Portfolio1.7.2025 18:21:00 CEST | Press release

Valeo Foods Group, one of Europe’s leading producers of quality sweets, treats and snacks, has successfully acquired the assets of an Italian panettone, pandoro and croissant producer, Melegatti 1894 S.p.A.This acquisition is another step forward in Valeo Foods Groups’ strategy to expand its baked sweet treats portfolio, and reinforces Valeo’s commitment to bringing authentic Italian confections and established regional brands to a wider international audience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702677156/en/ Melegatti Founded in 1894 in Verona, Melegatti has a strong reputation for artisanal cakes - particularly pandoro, panettone and filled croissants - traditional recipes, and a rich Italian heritage, Melegatti has a proud legacy founded on family values, craftsmanship, and a passion for quality. “We are excited to welcome Melegatti into the Valeo Foods Group,” said Ronald Kers, Group CEO. “This acquisition

PUMA and Borussia Dortmund Extend Partnership1.7.2025 18:18:00 CEST | Press release

Sports company PUMA has extended its long-standing partnership with Borussia Dortmund, and will continue to create products that cater to BVB’s many passionate fans around the world and match the club’s dynamic, fast paced style of football. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250701775493/en/ Sports company PUMA has extended its long-standing partnership with Borussia Dortmund, and will continue to create products that cater to BVB’s many passionate fans around the world and match the club’s dynamic, fast paced style of football. Since the start of their partnership in the 2012/13 season, BVB has celebrated many successes, such as reaching the finals of the 2012/13 and 2023/24 UEFA Champions League and winning the 2016/17 and 2020/21 German DFB Cup. The club is currently participating in the FIFA Club World Cup, where it has already reached the round of 16. BVB continues to set the standard in European football w

Gogo Galileo HDX Coming to Cessna Citation Jet Models1.7.2025 17:00:00 CEST | Press release

Expected FAA Supplemental Type Certification in late 2025 Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, today announced Gogo Galileo HDX will be available for aftermarket installation on Cessna Citation jets after Federal Aviation Administration (FAA) Supplemental Type Certification (STC) expected in late 2025. The global Low Earth Orbit (LEO) solution allows customers to enjoy one of the best possible in-flight connectivity and aviation experiences, no matter where their journey takes them. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250701750049/en/ Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, today announced Gogo Galileo HDX will be available for aftermarket installation on Cessna Citation jets after Federal Aviation Administration (FAA) Supplemental Type Certification (STC) expected in late 2025. (Photo: Textron Aviation) By offering Gogo Galileo HDX as an aftermarket upgrade, the Textron Av

Amos Food Wins Award at ESG Conference Held in Stuttgart1.7.2025 16:44:00 CEST | Press release

The 2nd Sino-European Corporate ESG Best Practice Conference, hosted by the Chinese Consulate General in Frankfurt, took place on June 26, 2025, in Stuttgart, Germany. Several companies were honored with Best Practice awards across six categories, with Amos Food Group receiving the Best Practice Award for Social Responsibility. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250701126324/en/ Amos Ma, Chairman of Amos Food Group, delivered a speech at the conference. With the theme “Together We Are Strong – For a More Innovative, Healthy, Intelligent, and Sustainable Future,” the conference was hosted by the Chinese Consulate General in Frankfurt in collaboration with German institutions including GIZ (German Society for International Cooperation), the Baden-Württemberg IHK (Chamber of Commerce and Industry), KPMG Germany, as well as Chinese partners including the China-Europe Business Council. According to the jury composed o

Chinese and European Enterprises Gather in Stuttgart to Discuss ESG Cooperation1.7.2025 16:19:00 CEST | Press release

The 2nd Sino-European Corporate ESG Best Practice Conference, hosted by the Chinese Consulate General in Frankfurt, was held on June 26th, 2025 in Stuttgart, Germany. Representatives from various sectors of China and Europe attended the event and agreed that ESG development is becoming a new focal point for exchange and cooperation between Chinese and European enterprises. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250701883046/en/ German participant tries the food of Beiwei 47 at the conference. Klaus Paal, President of the Stuttgart Chamber of Commerce and Industry, also emphasized that in today’s era of global transformation, ESG is a highly important topic and a key platform for enterprises from different countries to enhance communication and cooperation. Torsten Giehler, Director of the Economic and Social Development Department at GIZ (German Agency for International Cooperation), pointed out that ESG is no longer

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye