Dapagliflozin/Metformin Combo Nears EU Approval for Diabetes

November 22, 2013

Xigduo (AstraZeneca/Bristol-Myers Squibb), a 2-drug product for the treatment of type 2 diabetes and the first to combine metformin with a sodium-glucose cotransporter-2 (SGLT2) inhibitor, dapagliflozin (Forxiga, AstraZeneca/Bristol-Myers Squibb), has been granted a positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).

If approved, which is usually a formality within 67 days, Xigduo will be indicated for adults aged over 18 years with type 2 diabetes, and this will be the first approval for this product worldwide, an AstraZeneca spokesperson told Medscape Medical News.

It will be indicated as an adjunct to diet and exercise to improve glycemic control in those inadequately controlled on their current metformin-based treatment regimen; or in combination with other glucose-lowering medicinal products, including insulin, in patients inadequately controlled with metformin and these medicinal products; or for those who are currently receiving dapagliflozin and metformin as separate tablets.

Xigduo is intended as a twice-daily treatment and is available in 2 strengths: 5-mg dapagliflozin/850-mg metformin, and 5-mg/1000-mg film-coated tablets.

The SGLT-2 inhibitors work by reducing resorption of glucose in the kidney, resulting in increased urinary glucose excretion, with a consequent lowering of plasma glucose levels as well as weight loss.

Dapagliflozin was the first SGLT-2 inhibitor to be approved for the treatment of type 2 diabetes and is currently available in the 28 EU member states, as well as in Argentina, Australia, Brazil, Iceland, Mexico, Norway, and New Zealand.

Forxiga was rejected by the US Food and Drug Administration (FDA) in January 2012, however, because of concerns about its risk/benefit profile. At a July 2011 advisory committee meeting to discuss the drug, the panel voted 9 to 6 against recommending approval, primarily as a result of concerns about potential associations with breast and bladder cancer.

But the companies have now resubmitted a new drug application, and dapagliflozin will be reviewed again by an FDA advisory committee next month, on December 12.

Another SGLT-2 inhibitor, canagliflozin (Invokana, Janssen Pharmaceuticals), was the first in the class to be approved in the United States in March of this year. Clearance of a product combining canagliflozin with metformin is expected there any day. Canagliflozin is not available in the European Union, however.

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