Results

J&J boasts improved cardio safety with SGLT2 franchise drug Invokana

David Matthews, Steering Committee Co-Chair

J&J scored vitally important cardio safety data for its SGLT2 diabetes drug Invokana in a large Phase III outcomes study, which it happily shared with researchers at the annual American Diabetes Association conference in San Diego on Monday afternoon.

The pharma giant $JNJ spelled out a slate of positive risk reductions on three key measures, with a 14% reduction in risk for a composite score on CV mortality as well as nonfatal myocardial infarction and stroke, with each measure contributing to the positive score.

Investigators and payers can now pour over the results and start doing their comparisons with Jardiance, the rival SGLT2 drug from Eli Lilly $LLY and Boehringer Ingelheim which originally got this ball rolling two years ago. The big question now is whether this is a class effect that will eventually benefit all players, or provide enough data to start to single out one or two as better than the rest.

Class effect may be the favorite today, as J&J’s composite 14% reduction in risk matched Lilly’s overall number perfectly. Specialists, though, will note that not all the endpoints matched up, making cross trial comparisons tricky.

On the other hand Jardiance was more effective in cutting the risk of death (-38%) compared to a much more modest 13% reduction for Invokana, which achieved more balanced effects spread among endpoints. And Invokana was linked to a significantly higher risk of amputations, a safety concern that has already triggered a black box warning.

Additional analysis also demonstrated that Invokana (canagliflozin) lowered the risk of HHF by 33% (HR: 0.67; 95% CI: 0.52 to 0.87) and provided sustained positive effects on glycemic and blood pressure control, as well as weight reduction, with “wide-ranging durability,” J&J said in its statement. In addition, the pharma giant noted, their drug delayed progression of albuminuria and reducing the risk of clinically important renal composite outcomes (such as renal death, renal replacement therapy, and 40% reduction of eGFR) by 40%.

Merck $MRK and Pfizer $PFE only recently outlined their positive Phase III data for ertugliflozin, looking for an approval that will put them up against Invokana, Jardiance as well as AstraZeneca’s Farxiga. Their cardio outcomes data, though, isn’t expected until 2019, giving the leaders plenty of time to get further established first.

“Patients with diabetes are two to four times more likely to suffer from associated comorbidities, such as heart failure and kidney disease, and the CANVAS results demonstrate the potential of canagliflozin in reducing the risk for such conditions in high-risk type 2 diabetes patients,” said David Matthews, the trial’s steering committee co-chair and a professor of diabetic medicine at the University of Oxford. “These data are promising as they suggest canagliflozin may offer potential benefits for patients with type 2 diabetes, who are also facing complications from, or are at risk for, hospitalization for heart failure or kidney disease.”


Image: Shutterstock


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RAPS Regulatory Convergence 2017