Mundipharma Announces the Licence Extension Submission for Invokana® (canagliflozin) and Vokanamet® (canagliflozin and metformin) to the European Medicines Agency
STRICTLY FOR EUROPEAN MEDICAL AND PHARMACEUTICAL TRADE MEDIA ONLY
As the European distributor of Invokana® (canagliflozin) and Vokanamet® (canagliflozin and metformin), Mundipharma welcomes the news that the European Medicines Agency (EMA) has accepted the licence extension submission for these two medicines to treat stage 2 or stage 3 chronic kidney disease (CKD) and albuminuria as an adjunct to standard of care in adults with type 2 diabetes mellitus (T2DM). The submission is based on the results from the landmark Phase III CREDENCE study1 which evaluated the efficacy and safety of canagliflozin versus placebo in this high-risk patient population when used in addition to standard of care.
“Chronic kidney disease is a serious complication of type 2 diabetes, which can increase patients’ risk of developing end-stage renal disease and may reduce their life expectancy by several years.” said Dr Vinicius Gomes de Lima, European Medical Affairs Lead, Mundipharma. “If approved, this licence extension would be a significant step forward to help reduce the associated burden of chronic kidney disease and improve patients’ quality of life.”
Approximately 24 million T2DM patients in Europe are likely to develop diabetic kidney disease (DKD),2 which is projected to rise in line with the increasing prevalence of diabetes. DKD has a major impact on patients’ physical, emotional and financial wellbeing and amplifies the risk of diabetes complications including; cardiovascular disease, a reduced quality of life, infections, fatigue, depression, adverse drug reactions and premature death.3,4
In Europe, Invokana is currently indicated for the treatment of adults with insufficiently controlled T2DM as an adjunct to diet and exercise. The initiation dose is 100mg once daily in adults with an eGFR of ≥ 60 mL/min/1.73 m2 and can be increased to 300mg once daily orally if tighter glycaemic control is needed. Canagliflozin should not be initiated if eGFR is < 60 mL/min/1.73 m2. In patients tolerating canagliflozin whose eGFR falls persistently below 60 mL/min/1.73 m2 the dose should be adjusted to or maintained at 100mg once daily. Canagliflozin should be stopped if eGFR falls persistently below 45 mL/min/1.73 m2.5
The dose of glucose-lowering therapy with Vokanamet should be individualised on the basis of the patient’s current regimen, effectiveness, and tolerability, using the recommended daily dose of 100 mg or 300 mg canagliflozin and not exceeding the maximum recommended daily dose of metformin orally.6
Invokana and Vokanamet have been approved in the European Union since 2013 and 2014 respectively. In July 2018, the treatment labels were updated to include positive cardiovascular and renal outcomes from the CANVAS programme which show a reduction in morbidity and mortality.7
-END-
Notes to the editors:
About the CREDENCE Clinical Trial 1
The CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) study was the first dedicated and full 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, 2 arm multi-centre 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 at 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). The study was stopped early in July 2018 due to positive efficacy findings.
About Invokana®5
Invokana (canagliflozin) is an oral, once-daily medication which belongs to a class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors. SGLT2 inhibitors work by inhibiting SGLT2, which promotes the loss of glucose via the urine, lowering blood glucose levels in adults with T2DM. Invokana 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 contraindications and in addition to other medicinal products for the treatment of diabetes. Approval was based on a comprehensive global Phase III clinical trial programme.
About Vokanamet®6
Vokanamet (a fixed-dose combination of canagliflozin and metformin) is approved in the European Union for the treatment of adults with insufficiently controlled type 2 diabetes as an adjunct to diet and exercise. Vokanamet combines two oral glucose-lowering medicinal products with different and complementary mechanisms of action.
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 organization that strives for innovation and commercial excellence through partnerships, we successfully transformed and diversified our European portfolio of medicines to create value for patients, payers and wider healthcare systems across important therapeutic areas such as Diabetes, Respiratory, Oncology, Pain and Biosimilars.
References
1 Perkovic, V. et al. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. The New England Journal of Medicine. 2019; 380(24): 2295-2306.
2 Alicic R., et al. Diabetic Kidney Disease: Challenges, Progress, and Possibilities. Clin J Am Soc Nephrol. 2017; 12(12): 2032-2045.
3 CDC. National Chronic Kidney Disease Fact Sheet, 2017. Available at: https://www.cdc.gov/kidneydisease/pdf/kidney_factsheet.pdf. Last accessed July 2019
4 Thomas M., Cooper M., and Zimmet P. Changing epidemiology of type 2 diabetes mellitus and associated chronic kidney disease. Nature Review Nephrology. 2016; (12): 73-81
5 Invokana SmPC. Available at: https://www.ema.europa.eu/en/documents/product-information/invokana-epar-product-information_en.pdf Last accessed July 2019
6 Vokanamet SmPC. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/SGLT2_inhibitors 20/European_ Commission_final_decision/WC500206514.pdf. Last accessed July 2019
7 Neal B et al. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. The New England Journal of Medicine. 2017; 377:644-657
Job code: MBL/DIAB-19020
Date of preparation: August 2019
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190821005555/en/
Contact information
Patrice Grand
European Director of Corporate Communications, Mundipharma Ltd
Email: Patrice.Grand@Mundipharma.com
Abbie Bell
Senior Account Manager, Havas SO
E-mail: Abbie.Bell@HavasSO.com
Tel: +44 (0) 20 3196 9919
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Paysafe Research: First-Time and Casual Betting to Surge for 2026 World Cup14.1.2026 16:10:00 EET | Press release
19% of global consumers with an interest in following this summer’s 2026 World Cup plan to place their first ever online bet during the soccer tournament, according to research issued today by leading payments platform Paysafe (NYSE: PSFE). The company’s All the Ways Players Pay: World Cup 2026 report also indicates that brand reputation and offering flexible, reliable payments will be crucial for online sportsbooks when converting and retaining new and experienced bettors alike. With the World Cup returning to North America for the first time since 1994, there is strong appetite for online wagering in the host countries of the U.S., Mexico, and Canada as well as in Europe and Latin America, with 60% of global fans planning to bet. Across U.S. states where sports betting is legal, 62% intend to wager, with 29% placing their first ever bet. The surge is expected to be even stronger in Mexico, with 68% planning to wager, including 26% for the first time. And even in Canada, 46% of Ontari
Joint Cross-industry Statement: Cement Industry Co-Processing Should Be More Widely Adopted for Global Sustainable Waste Management14.1.2026 16:00:00 EET | Press release
Leading industry organisations today issued a joint statement highlighting the substantial and positive contribution the cement industry can make to addressing the urgent global challenge of non-recyclable and non-reusable waste. The Global Cement and Concrete Association – GCCA; European Composites Industry Association (EuCIA); International Solid Waste Association – Africa; Mission Possible Partnership; and The Global Waste-to-Energy Research and Technology Council – WtERT® are calling for stronger policy support to unlock the full potential of cement industry co-processing as a safe, effective and sustainable global waste management solution. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260114232332/en/ Co-processing enables both energy recovery and material recycling. It uses waste to replace fossil fuels in heating cement kilns, while any remaining ashes are simultaneously recycled into the building material compound
New Experian Study Reveals Critical Role of AI in Lending and Key Drivers of Accelerated Adoption by Financial Institutions14.1.2026 16:00:00 EET | Press release
A recent Experian Perceptions of AI Report that polled more than 200 decision-makers at leading financial institutions on their AI investment strategy offers key insights into their adoption of AI and expected outcomes when investing in the technology. Notably, AI adoption among financial institutions is accelerating, with 84% of respondents identifying AI technology as being critical or a high priority for their business strategy over the next two years. Further underscoring AI’s strategic importance, a striking 89% state that it will play a critical role across the lending lifecycle. Study findings shed light on that role, pointing to several essential outcomes that respondents expect when investing in AI, including increased operational efficiency, improved credit decisioning accuracy and more effective risk mitigation. “This study helps us better understand the business drivers behind the strong and increasingly fast-moving investments in AI among our financial institution customer
Prometheus Announces Breakthrough e-Kerosene Pathway to Make Cost-Competitive SAF and Diesel from Electricity and Air14.1.2026 15:57:00 EET | Press release
Prometheus Fuels today announced its revolutionary new pathway for producing synthetic paraffinic kerosene (the basis for SAF jet fuel and e-diesel) from direct air capture of CO2 and off-grid renewable electricity. The new Prometheus e-kerosene pathway makes Fischer-Tropsch synthesis obsolete, reducing the cost to make e-fuels by more than 80 percent compared to the century-old technology. It is also the first process in history to make kerosene from electricity and atmospheric CO2 without using hydrogen. The kerosene produced is 100 percent carbon neutral. Two independent engineering reviews confirmed demonstration of the new pathway using commercial-scale cells. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260114310118/en/ Because the Prometheus e-kerosene pathway operates at ambient temperatures and pressures, it uses much less expensive equipment than the high-temperature, high-pressure Fischer-Tropsch process. This i
Armis Launches New Partner Program, Expanding its Reach to Help Global Organizations Enhance Cyber Resilience14.1.2026 15:00:00 EET | Press release
Armis, the cyber exposure management & security company, today announced the launch of the Armis Select Partner Program. The new program marks a significant evolution in Armis' commitment to its global partner ecosystem. By extending the reach of Armis Centrix™, the Armis Cyber Exposure Management Platform, to organizations worldwide through its partner program, joint customers can streamline their security operations and proactively strengthen defenses. “Global enterprises don’t just need tools; they need a unified ecosystem of trusted partners to navigate an increasingly volatile threat landscape,” said Alex Mosher, President and CRO of Armis. “At Armis, our partners are the primary engine of our growth and the cornerstone of our global strategy. By evolving our partner program, we are doubling down on this collaborative foundation to accelerate our reach and deepen our impact. Together, we are empowering customers to move from reactive defense to proactive cyber exposure management
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