- Johnson & Johnson's Invokana cut the risk of cardiovascular (CV) death or hospitalization for heart failure (HHF) in high cardiovascular risk patients with type 2 diabetes in its CANVAS study, in late-breaking data presented on Sunday at the American College of Cardiology’s 67th Annual Scientific Session.
- Invokana, an SGLT-2 inhibitor from the J&J's Jannsen Biotech unit, cut the risk of CV death or HHF by 22%, and HHF alone by 30%. The benefit was greater in patients with a prior history of heart failure.
- Janssen has submitted a supplemental New Drug Application to the Food and Drug Administration for the use of Invokana to reduce the risk of major adverse CV events (MACE).
Cardiovascular disease drives about two-thirds of the deaths of adults with type 2 diabetes.
"Hospitalization for heart failure and, even worse, cardiovascular death are on the minds of many doctors and patients who manage type 2 diabetes," said Robert Cuddihy, VP of medical affairs, cardiovascular & metabolism at Janssen Research & Development.
Results from CANVAS presented in June 2017 showed positive effects on heart health for Invokana (canagliflozin), but there were concerns that the improvement wasn’t as great as Eli Lilly & Co. and Boehringer Ingelheim's Jardiance (empagliflozin), another SGLT-2 inhibitor. Results of the CANVAS study suggest that there could be a class-wide effect for SGLT-2 inhibitors, and that they all lower the risk of CV complications.
One piece of evidence that may support Invokana's use, however, is the latest finding that drug shows a 39% greater benefit in patients with a prior history of heart failure. This could be a helpful differentiator.
"These results add to the body of evidence suggesting that canagliflozin has clinical benefit in patients with type 2 diabetes who are also at risk for some of the major cardiovascular complications," said Javed Butler, chair of medicine at University of Mississippi, cited in a Janssen statement.
Already on the market for type 2 diabetes, if Invokana gets the additional cardiovascular indication it will go head to head against Jardiance. The latter gained its add-on cardiovascular approval from the Food and Drug Administration in December 2016. This was the first approval of its type.
AstraZeneca's Farxiga (dapagliflozin), approved in 2014, has shown cardiovascular risk reduction in its CVD-REAL study, and the cardiovascular outcomes trial, DECLARE, is expected to read out by 2019.
Merck & Co. and Pfizer Inc.’s type 2 diabetes drug Steglatro (ertugliflozin) is the fourth to enter the market, approved in December 2017. Its VERTIS CV study completed enrollment last summer, with completion expected in 2019. Lexicon Pharmaceuticals Inc.'s sotagliflozin is in Phase 3 in type 2 diabetes.