In a huge boon for Lilly and Boehringer Ingelheim, US regulators have expanded the scope of diabetes drug Jardiance to include a reduction in the risk of cardiovascular death patients with type II forms of the condition and cardiovascular disease.
According to the Centers for Disease Control and Prevention, death from cardiovascular disease is 70 percent higher in adults with diabetes compared to those without diabetes, and patients with diabetes have a decreased life expectancy driven in large part by premature cardiovascular death.
In a post-marketing study involving more than 7,000 patients ordered by the agency when it first approved Jardiance (empagliflozin) in 2014, the drug was shown to reduce the risk of cardiovascular death by 38 percent when added to standard of care in type II diabetics at high risk of CV events.
The once-daily pill also also reduced the overall risk of having a non-fatal heart attack or stroke or death from cardiovascular causes by 14 percent, while all-cause mortality was slashed 32 percent and hospitalisation for heart failure 35 percent.
"Cardiovascular disease is a leading cause of death in adults with type II diabetes mellitus," said Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products in FDA's Center for Drug Evaluation and Research. "Availability of antidiabetes therapies that can help people live longer by reducing the risk of cardiovascular death is an important advance for adults with type II diabetes."
Jardiance belongs to the sodium glucose co-transporter 2 (SGLT2) inhibitor class of medicines, which also includes Johnson & Johnson's Invokana (canagliflozin) and AstraZeneca Forxiga (dapagliflozin).
Boehringer announced earlier this year that it would explore whether Jardiance can also benefits to patients with heart failure, with plans for two outcome trials that will enrol both patients with type II diabetes and those without.