- Johnson & Johnson revealed late Monday it will stop early due to efficacy a clinical trial of its type 2 diabetes medicine Invokana in chronic kidney disease patients who also had diabetes.
- The company did not yet have results of the Phase 3 study, but halted it based on a recommendation from a Independent Data Monitoring Committee.
- The CREDENCE trial began over four years ago and included 4,400 type 2 diabetes patients with established chronic kidney disease. It was conducted to test whether Invokana could prevent, or improve, renal and cardiovascular outcomes in these patients.
The news comes just in time for Johnson & Johnson. The multinational conglomerate announced second quarter earnings on Tuesday morning, revealing worldwide sales of the diabetes medication were down 27% year over year to $215 million in the period from April to June.
While Invokana (canagliflozin) was the first SGLT-2 inhibitor to enter the market when J&J launched it in 2013, it now faces multiple rivals from the same class, as well as competition from other diabetes drugs. Invokana is still the class leader by sales, but revenues have been on a downward trend for several quarters.
The landscape for SGLT-2 inhibitors changed when Eli Lilly and Boehringer Ingelheim announced the results of a cardiovascular outcomes study dubbed EMPA-REG for their SGLT-2 inhibitor Jardiance (empagliflozin), showing the drug reduced cardiovascular risks in type 2 diabetes patients. Since that data came out, other drugs in the class —including Invokana — have shown a similar benefit, pointing to a class-wide effect.
While Lilly had hoped the EMPA-REG study would boost results for Jardiance, that has been slow to come to fruition.
Like Lilly, J&J is hoping that the CREDENCE study will be the differentiator the company needs to turn around sales of the drug. Currently, Invokana is contraindicated for use in patients with severe renal impairment, end-stage renal disease or who are on dialysis. Yet, chronic kidney disease is a major comorbidity of diabetes and nearly half of all types 2 diabetes patients will develop the condition.
Most recently, J&J inked a collaboration with Merck KGaA to have the German company market Invokana in China, where diabetes is a growing epidemic.