US patients with type II diabetes have gained a new treatment option after regulators approved Boehringer Ingelheim/Eli Lilly’s Jardiance (empagliflozin).
The move, which comes just a couple of months after European approval, provides a new means of improving glucose levels which are still often poorly controlled despite a variety of therapies on the market, leaving patients at greater risk of developing serious complications.
Jardiance belongs to the sodium glucose co-transporter-2 (SGLT2) inhibitor class of drugs, which work by blocking reabsorption of glucose in the kidney and increasing its excretion to lower blood sugar levels in adults with the condition (but not those with type I).
FDA approval is based on data from a large clinical program involving more than 13,000 type II diabetics, which showed that the pill significantly reduced haemoglobin A1C and fasting blood sugar after 24 weeks as a stand-alone treatment or in combination with a range of background treatments, such as metformin.
And while the drug has not been specifically cleared for lowering weight or blood pressure, “modest reductions in both weight and systolic blood pressure were observed in clinical trials,” the firms noted, signalling a further potential benefit to patients.
On the safety side, the most common side effects linked to Jardiance were urinary tract infections and vaginal yeast infections, and hypoglycaemia was more commonly reported in patients treated with a combination of the drug and sulfonylurea or insulin.
Around 29 million Americans and an estimated 382 million worldwide have diabetes, of which type II accounts for around 85% -95%.