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SAN FRANCISCO – Johnson & Johnson and his fellow drug manufacturers SGLT2 are all working to show the benefits for patients with kidney disease. But in this group, J & J can boast about the data that its rivals do not have.
On Tuesday, at the annual meeting of the American Diabetes Association, Janssen's J & J unit presented a new analysis based on the kidney test, Credence. The study showed that Invokana could be beneficial for all diabetic patients with chronic kidney disease (CKD) with or without known cardiovascular disease.
"What we have seen is very consistent results, both on renal parameters and on cardiovascular endpoints in these patients," said Jim List, head of research and development on metabolism and cardiovascular disease. at Janssen.
The results make the latest sub-analysis "perhaps the most intriguing or the most exciting" group, said List, stressing that "this is the first time for a SGLT2 that there is strong evidence of cardiovascular benefit for patients without known cardiovascular disease. "
RELATED: An Invokana Victory in Kidney Patients Could Help J & J Take the SGLT2 Boat
The new findings follow up on the April presentation of the Credence study, which showed that the addition of Invokana to standard treatment could delay the course of kidney disease. Invokana also showed that it could reduce by 31% the risk of cardiovascular death and hospitalization related to heart failure in patients with diabetic nephropathy.
Based on these findings, regulators granted the drug a priority review in May, setting it up for a new homologation – and a chance for an increase in sales that its rivals did not have – later this year. And Invokana, who has been hampered by the amputation and his rivals can not stand anymore, could use a lift in the sales department after two consecutive years of decline.
RELATED: Invokana from Johnson & Johnson is getting close to kidney failure if necessary with FDA priority
Although the approval of CKD is unique, Invokana is not the only member of the SGLT2 class to publish ADA-positive kidney data. On Sunday, AstraZeneca unveiled an analysis of the Declare cardiovascular effects study, which shows that its competitor, Farxiga, could lead to a 47% reduction in the combined risk of declining renal function, end-stage renal failure, and renal death in patients with type 2 diabetes.
For their part, Eli Lilly and Boehringer Ingelheim have published a post-hoc analysis of the Empa-Reg Outcome study showing that Jardiance could reduce cardiovascular and renal risks in adult diabetics with cardiovascular disease and a form of chronic kidney disease without high protein level. urine.
But as List noted, "There is only one study on renal outcomes done in the SGLT2 class and it's Credence."
Other analyzes are "hypothesis-generating, but they do not have the power or the desired population" to show the effects demonstrated by Invokana, he said, adding that "others are returning to their bases. data and try to find similar effects. think, highlights the importance of these results. "
That's not to say that AZ and the BI-Lilly team are not working to produce the same kind of data that J & J has now. In 2016, AstraZeneca launched a Phase IIIb study on Farxiga in the treatment of chronic renal failure. BI and Lilly, in 2017, announced plans to launch a similar results study for Jardiance.
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