J&J’s Invokana closes on diabetic kidney disease approval

The US FDA has granted a priority review to Johnson & Johnson’s Invokana in diabetic kidney disease, signposting an end to a 20-year drought on new therapies.

The filing was actually made back in March, based on the results of the phase 3 CREDENCE trial, and if approved SGLT2 inhibitor Invokana (canagliflozin) will be the only diabetes drug approved for this indication, giving it a leg-up over other therapies.

The priority review means the FDA will now review J&J’s marketing application in six months rather than the usual 10, setting up a possible approval in September.

CREDENCE found that Invokana was able to reduce the risk of end-stage kidney disease, the doubling of kidney health marker serum creatinine, and renal or cardiovascular death by 30% in adults with type 2 diabetes who also had chronic kidney disease (CKD).

Diabetes is the leading cause of CKD, and around one in four diabetics has it – equivalent to millions of people worldwide. That means the results are a defensive opportunity for Invokana, which has seen its sales decline in part because of tougher competition in the diabetes market, with sales sliding 21% to $881 million last year, but more so because of safety concerns.

The drug has been linked to an increased risk of lower limb amputations that resulted in a black box warning being added to its label in 2017 and saw its working beefed up earlier this year.

Last year’s decline in sales came despite approval of a cardiovascular risk reduction claim by the FDA last October based on the CANVAS trial, and the franchise lost another 19% in the first three months of this year, declining to just over $200 million.

“We are pleased the FDA recognises the urgency to deliver a novel treatment that can reduce the risk of kidney failure and prevent life-threatening cardiovascular events in people with type 2 diabetes and chronic kidney disease,” said James List, who heads the cardiovascular and metabolism unit at J&J’s Janssen pharma unit.

Discussion the CREDENCE data on J&J’s first-quarter results call last month, J&J’s pharma chair Jennifer Taubert said that the company will “work with the regulators to get an indication along those lines, and then…work with payers to see if we've got the opportunity to enhance our formulary positions and get this product available for more patients.”

Several other diabetes drug developers are also chasing this indication – although AstraZeneca is taking the approach one step further by testing its Forxiga (dapagliflozin), a rival SLGT-2 class therapy, in patients with chronic kidney disease without diabetes.