EU Regulators Recommend Glyxambi for Diabetes

Disclosures

September 16, 2016

European Union (EU) regulators yesterday recommended approval of the combination drug empagliflozin/linagliptin (Glyxambi, Boehringer Ingelheim International GmbH) to treat adults with type 2 diabetes.

Both drugs lower blood glucose. Empagliflozin is a sodium glucose cotransporter 2 (SGLT2) inhibitor that causes patients to excrete blood glucose in their urine, while linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, indirectly stimulates insulin production.

The combination drug will be available as film-coated tablets with either 10 mg of empagliflozin and 5 mg of linagliptin, or 25 mg of empagliflozin and 5 mg of linagliptin, according to a news release from the European Medicines Agency (EMA). Empagliflozin/linagliptin is indicated specifically for adults with type 2 diabetes who do not achieve adequate glycemic control taking one of the new drug's components in combination with either metformin or a sulfonylurea, or both.

Urinary tract infections are the most common adverse event associated with the diabetes drug. Ketoacidosis, pancreatitis, hypersensitivity, and hypoglycemia are the most serious adverse events.

The diabetes drug was approved by the US Food and Drug Administration (FDA) in February 2015. Later that year, the FDA revised the labels of empagliflozin and other SGLT2 inhibitors to warn that, whether alone or in combination with another drug, they may cause ketoacidosis and serious urinary tract infections.

The recommendation to approve empagliflozin/linagliptin for use in the EU was made by EMA's Committee for Medicinal Products for Human Use. The European Commission, the EU's executive branch, will render a final decision.

More information on today's EMA action is available on the agency's website.

Follow Robert Lowes on Twitter @LowesRobert

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