Glyxambi recommended for European approval to treat type 2 diabetes patients

The combination drug Glyxambi, manufactured by Boehringer Ingelheim, has been recommended for European approval to treat adults with type 2 diabetes.
It combines Jardiance (empagliflozin), a sodium glucose cotransporter 2 (SGLT2) inhibitor, with the dipeptidyl peptidase-4 (DPP-4) inhibitor Tradjenta (linagliptin) in a once-daily dose.
It will be available as film-coated tablets containing either 10 mg of empagliflozin and 5 mg of linaglipti, or 25 mg of empagliflozin and 5 mg of linagliptin.
Both drugs lower blood glucose. Empagliflozin causes patients to excrete blood glucose in their urine, while linagliptin indirectly stimulates insulin production.
They are indicated in co-therapy for patients with type 2 diabetes aged 18 years and older who do not achieve adequate blood sugar control taking one of the new drug’s components in combination with either metformin or a sulphonylurea, or both.
However, it is not recommended in patients with type 1 diabetes.
According to a news release from the European Medicines Agency (EMA), there are a number of serious adverse effects associated with Glyxambi use, such as hypoglycemia, hypersensitivity, pancreatitis, and diabetic ketoacidosis.
Urinary tract infections are the most common side effect (7.5 per cent with Glyxambi 10 mg/5 mg and 8.5 per cent with Glyxambi 25 mg/5 mg).
Other significant adverse reactions listed are hypoglycemia, hypersensitivity, pancreatitis, and diabetic ketoacidosis.
To limit hepatic impairment, it is recommended to assess renal function before initiating such a treatment and periodically thereafter.
The diabetes combination drug, which is one of the first and only diabetes treatment to capitalise on the dual mechanisms of action of SGLT2 and DPP-4 inhibitors, received the US Food and Drug Administration’s approval in February 2015.
Shortly after, The FDA revised the labels of empagliflozin and other SGLT2 inhibitors to warn about the risks for ketoacidosis and urinary tract infections when used alone or with another drug.
The recommendation to approve Glyxambi as an adjunct to diet and exercise for use in the EU was made by EMA’s Committee for Medicinal Products for Human Use (CHMP). The European Commission (EC) will render a final decision.