Mundipharma submits license extension for Invokana & Vokanamet to EMA
Category: #health  By Pankaj Singh  Date: 2019-08-23
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Mundipharma submits license extension for Invokana & Vokanamet to EMA
  • CREDENCE renal outcome study, that was stopped early because of positive efficacy findings, laid the foundation for submission of license extension.
     
  • Invokana® will be the first treatment in approximately 20 years indicated towards decreasing the end stage renal disease risk, if approved.

Mundipharma, a Cambridge based pharmaceutical company, reportedly announced the acceptance of license extension for Invokana® (canagliflozin) as well as Vokanamet® (canagliflozin and metformin) medicines by European Medical Agency (EMA).

These medicines are used to treat stage 3 or stage 2 Chronic Kidney Disease (CKD) as well as albuminuria being an adjunct for standard of care in adults with T2DM (Type 2 Diabetes Mellitus). The extension submission is based on outcomes of Landmark Phase 3 CREDENCE study that examined the safety and efficacy of canagliflozin against placebo in high-risk patient groups when used along with standard of care.

About 24 million patients with T2DM across Europe are susceptible to diabetic kidney disease (DKD). DKD is projected to increase in line with growing prevalence of diabetes. DKD has a substantial effect on an individual’s financial, physical and emotional wellbeing and increases the risk of diabetes complications which include adverse drug reactions, fatigue, cardiovascular disease, infections, depression, decreased life quality and premature death.

European Medical Affairs Lead at Mundipharma, Dr Vinicius Gomes de Lima, stated that CKD is a severe complication that falls under type 2 diabetes, that can potentially grow risk of end-stage renal disease and decrease the patients’ life expectancy by many years.

Dr Vinicius added that if the license extension is approved it would be the next step towards decreasing the burden of CKD and gradually increase victim’s quality of life. 

Invokana and Vokanamet are authorized, since 2013 & 2014 respectively, in the European Union. Treatment labels were updated, in 2018 in the month of July, to also include positive renal and cardiovascular outcomes from CANVAS program which shows a decrease in mortality and morbidity.

 

Source Credit: https://www.businesswire.com/news/home/20190821005555/en/Mundipharma-Announces-Licence-Extension-Submission-Invokana%C2%AE-canagliflozin



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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