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J&J’s Invokana first SGLT2 to show kidney disease benefits

Could help revival after amputation risk scare

J&J

Johnson & Johnson's diabetes drug Invokana has shown it can slow down kidney disease or even prevent it all together.

The results from the phase 3 CREDENCE study are an important boost for Invokana, which is trailing behind other competitors in the SGLT2 inhibitor class in terms of market share.

Invokana has been in decline ever since the FDA added a label warning of lower-limb amputations risk in 2017, with the drug suffering a 21% sales drop last year.

The company is looking to reassure doctors and patients about the safety of Invokana, and recently revealed real-world data that found no amputation risk for the drug - but this safety scare will prove hard to shake off. However, the new safety data, coupled with the new phase 3 CREDENCE results, could help J&J make up lost ground.

Results from the CREDENCE study, which evaluated type 2 diabetes patients with chronic kidney disease, showed that those taking the once-daily pill had a 30% lower risk of kidney failure, dialysis requirement, kidney transplant or death than those in the placebo arm.

Kidney disease is a common condition associated with diabetes, but Invokana could become the first medicine to gain a new addition to its US label, claiming a reduction in risk of renal failure when added to standard of care.

James List

James List

"Diabetes is the leading cause of kidney failure for millions of people worldwide, and this clear need for a new treatment option was the motivation for initiating the CREDENCE study,” said James List, Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development.

“We are pleased to share study results that potentially could establish Invokana as the only medicine to safely reduce the risk of renal failure in this high-risk patient population when added to current standard of care.

"We are working closely with the US FDA and health authorities worldwide to bring this important medicine to those living with these life-threatening conditions."

The drug also reduced the risk of cardiovascular (CV) death and hospitalisation for heart failure by 31%, major adverse CV events by 20%, and the risk of hospitalisation for heart failure alone by 39%.

The trial puts Invokana one step ahead of rivals, such as AstraZeneca, the renal outcomes study for its SGLT2 drug Farxiga due in November 2020.

Meanwhile Sanofi and Lexicon's Zynquista and Eli Lilly and Boehringer Ingeheim's market leader Jardiance are also both in renal outcomes trials, with their respective results expected by 2022. It seems likely that the other drugs in the class will also prove their value in kidney disease - just as protection against heart disease has been proven in cardiovascular outcomes trials across the class.

Analysts expect Jardiance to maintain its lead in the field over this period, with Evaluate Pharma forecasting it will hit revenues of $3.51bn by 2024.

15th April 2019

From: Research

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