European regulators have agreed to review Boehringer Ingelheim and Eli Lilly’s empagliflozin as a treatment for type II diabetes.
The drug, which was developed through the BI and Lilly Diabetes Alliance, was also recently filed across the pond with US regulators, the groups said this week.
The filings were triggered by the completion of Phase III registration trials, which showed that empagliflozin significantly reduced blood glucose levels compared to placebo.
Christophe Arbet-Engels, vice president of metabolic-clinical development and medical affairs at BI, said the firms are “excited” to have submitted the application for “a potential new treatment option that may help patients better manage their type II diabetes mellitus”.
Around 371 million people around the globe are thought to have diabetes, with type II forms of the condition accounting for about 90% of cases.
The disease is estimated to have cost the US economy alone $245 billion in direct medical costs and reduced productivity in 2012, and with its soaring prevalence, the situation looks set to get much worse.
A significant proportion of patients fail to keep their blood glucose levels under control, putting them at greater risk from developing complications of the disease, and highlighting the need for better management of the condition.
Rival for Forxiga?
Empagliflozin is a member of the SGLT2 inhibitor class of drugs, which work by removing excess glucose through urine by preventing its re-absorption in the kidney.
If given the green light, it will compete in Europe with AstraZeneca/Bristol-Myers Squibb’s first-in-class offering Forxiga (dapagliflozin), which was approved in November last year.
A large-scale clinical trial programme assessing empagliflozin for diabetes type II is still underway, with plans to enrol more than 14,500 patients across 12 multinational Phase III studies, results of which are expected throughout this year and next.
