FDA gives approval JnJ new kidney disease

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Johnson & Johnson’s Invokana has become the only drug in the SGLT2 inhibitor class to be approved by the FDA for treating diabetic kidney disease (DKD) and to reduce the risk of hospitalisation for heart failure in patients with type 2 diabetes and DKD.

Based on results of the CREDENCE trial, J&J’s drug reduced the risk of kidney failure by 30%, cut cardiovascular death and hospitalisation for heart failure by 31% and reduced major adverse CV events by 20% when added to standard treatment with ACE inhibitors or angiotensin II receptor blockers.

Additionally, the risk of hospitalisation for heart failure fell by 39% with Invokana compared to placebo.

Invokana was the first SLG2 inhibitor to reach the market for diabetes after it was approved by the FDA in 2013, and sales rose quickly to reach almost $1.4bn in 2016, before the addition of a black box warning in 2017.

Sales however have been declining, on average, by 20% a year, coming in at $881 million last year as other rivals such as Eli Lilly and Boehringer Ingelheim’s Jardiance as well as AstraZeneca’s Farxiga (dapaglifozin) have gathered momentum.

In the United States, one in three people with type 2 diabetes has DKD, which multiples the risk of cardiovascular complications including heart failure and furthermore puts patients on a trajectory to dialysis and kidney transplantation.

James List, Global Therapeutic Area head, Cardiovascular & Metabolism and Janssen, said: “With the approval of these new uses Invokana is now the only diabetes medicine indicated to help type 2 diabetes patients reduce the risks associated with diabetic kidney disease, including hospitalisation for heart failure.

“This significant advancement addresses serious unmet needs and could change the trajectory of care for the many millions of patients living with type 2 diabetes and diabetic kidney disease.”

Source: Pharmafile