Lilly/Boehringer diabetes combos get cardio data boost

Eli Lilly and Boehringer Ingelheim can include data showing cardiovascular benefits of their diabetes drug, empagliflozin, on US labels of combination drugs that include it.

Last month the FDA granted a landmark permission for the companies to promote the drug, known under the brand name Jardiance, as a way for diabetes patients to reduce their risk of having a heart attack or stroke.

This made Jardiance the first ever diabetes drug to carry such a claim, and should eventually help turn the drug into a market leader among oral treatments.

The claim is based on the companies' EMPA-REG outcome trial, which showed the drug reduced the risk of cardiovascular death compared with placebo when added to standard of care type 2 diabetes and cardiovascular medicines, in adults with type 2 diabetes and established cardiovascular disease.

EMPA-REG showed empagliflozin cuts relative risk of overall cardiovascular death by 38% in adults with type 2 diabetes with cardiovascular disease.

The drug is also available in two combinations Synjardy (empagliflozin+metformin), Synjardy XR, and Glyxambi (empagliflozin+linagliptin) - and the labels for these products are now permitted to refer to the data.

However the companies stress that Synjardy and Glyxambi can't carry the full claims of effectiveness reducing risk of cardiovascular death, as these combinations were not used in the pivotal trial.

Nevertheless, the changes will give a further boost to Lilly and Boehringer in the tough US diabetes market. Rival SGLT2 inhibitors, Janssen’s Invokana (canagliflozin) and AstraZeneca’s Farxiga (dapagliflozin) and combinations have been hit by a series of safety warnings.

The FDA requires cardiovascular safety data for all diabetes drugs, after older drugs were found to have raised the risk of heart problems. Pharma companies have turned this to their advantage by producing medicines with a double effect of treating disease, and reducing cardiovascular events.

Lilly and Boehringer co-market the medicines as part of an alliance they struck six years ago.