Jardiance is first diabetes drug to improve CV outcomes

Lilly and Boehringer Ingelheim's Jardiance has become the first diabetes therapy to lower the risk of cardiovascular disease in a clinical trial.

It is well known that diabetes raises the risk of cardiovascular complications such as heart attack, stroke and death, but to date no study has shown conclusively that careful control of blood glucose in diabetics can lower risk.

Now, the results of the 7,000-patient EMPA-REG OUTCOME trial show that adding SGLT2 inhibitor Jardiance (empagliflozin) to standard therapy for type 2 diabetes cut cardiovascular risk significantly, although for now the two companies have not revealed the scale of the benefit.

"The cardiovascular risk reduction Jardiance demonstrated … is exciting and we look forward to sharing the full results," said Prof Hans-Juergen Woerle, global vice president medicine at Boehringer.

"Approximately 50% of deaths in people with type 2 diabetes worldwide are caused by cardiovascular disease. Reducing cardiovascular risk is an essential component of diabetes management," he added.

Adding a cardiovascular outcomes claim to the label for Jardiance would be a massive boost for the drug and help it gain ground on other oral diabetes drugs, including rival SGLT2 inhibitors Invokana (canagliflozin) from Johnson & Johnson and AstraZeneca's Forxiga/Farxiga (dapagliflozin).

Invokana currently leads the SGLT2 inhibitor category with sales of $568m in the first half of the year, while Forxiga brought in $205m for AZ. Lilly indicated in its second-quarter results statement that sales of third-to-market Jardiance were "not material" in the first half of the year.

It will also help to offset some of the negative impact of an FDA warning earlier this year that SGLT2 inhibitors may be linked to high levels of blood acids that could require hospitalisation.

At the time, analysts said the warning could peg back growth in the class and boost other diabetes drugs such as the DPP4 inhibitors, led by Merck & Co's $6bn Januvia (sitagliptin) brand. However, the DPP-4 inhibitors have so far been unable to show an improvement on cardiovascular outcomes in trials.

Detailed results of the EMPA-REG OUTCOME trial will be presented on September 17 at the European Association for the Study of Diabetes (EASD) annual meeting in Stockholm, Sweden.

The trial is comparing two doses of Jardiance - 10mg and 25mg - with placebo and the primary outcome measure is the time to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke.