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J&J’s Invokana aces diabetic kidney disease trial, setting up filings

It could be the first new drug in 15 years to slow kidney damage development

Johnson & Johnson’s SGLT2 inhibitor Invokana worked so well in a trial involving diabetics with chronic kidney disease that the study has been halted early – potentially opening up a lucrative new market for the drug.Invokana

The large-scale CREDENCE trial pitted Invokana (canagliflozin) against placebo in type 2 diabetics with established CKD on top of standard therapy. It stopped at the interim stage after it became apparent that J&J’s drug significantly reduced the risk that patients would go on to develop end-stage kidney disease requiring dialysis or transplantation.

That was part of a composite endpoint in the trial which also included the time to doubling of serum creatinine – a biomarker of kidney damage – and renal or cardiovascular death. The data itself is being kept under wraps pending presentation at a medical conference, but J&J says it is preparing to run it past regulators as well.

If approved, Invokana would become the first new drug in 15 years to slow the development of kidney damage in diabetics after the angiotensin receptor blockers, and that could open up a big new market at a time when Invokana is feeling the pinch.

Just over a year ago, regulators slapped a black box warning onto the label for J&J’s drug after the results of the CANVAS trial suggested it may increase the risk of lower-limb amputation in diabetics, putting it at a disadvantage compared to rival SGLT2 drugs such as Eli Lilly and Boehringer Ingelheim's Jardiance (empagliflozin) and AstraZeneca’s Farxiga (dapagliflozin).

Since then J&J has been trying to restore confidence in its product – publishing real-world data from a massive registry study last month which backed its safety and also found it cut hospitalizations due to heart failure – but in the meantime has seen sales go into reverse. Sales fell to $1.1bn last year from $1.4bn in 2016, a trend that continued into the first quarter with a 13% slide to $248m. J&J hasn’t mentioned anything yet about safety data from CREDENCE.

Meanwhile, its efforts get the positive cardiovascular outcomes data from CANVAS onto Invokana’s label have been delayed with the FDA extending its review for three months earlier this week.

Nearly half of all people with type 2 diabetes will develop chronic kidney disease, which means 160m people worldwide are at risk, according to J&J.

“This huge unmet need is why it was so important for us to initiate the landmark CREDENCE renal outcomes trial over four years ago,” said Vlado Perkovic of the University of New South Wales and George Institute for Global Health in Australia, who co-chaired the trial’s steering committee.

“We have accepted the advice of the independent data monitoring committee to stop the CREDENCE trial early due to demonstration of efficacy, and look forward to sharing the findings as soon as possible.”

Article by
Phil Taylor

17th July 2018

From: Research



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