First Approval for Flozin/Metformin Combo in EU


January 22, 2014

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 approved in the European Union.

Xigduo will be indicated for adults aged over 18 years with type 2 diabetes, and this is the first approval worldwide for any product combining an SGLT2 inhibitor with metformin, the companies note. A similar fixed-dose combination of another drug in this class, canagliflozin (Invokana; Janssen) with metformin, was just rejected by the US Food and Drug Administration, which said it needs more information before it can approve the dual agent.

Xigduo is 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.

The product 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. It has also recently been cleared for marketing in the US, at the second attempt.

Canagliflozin was the first in the SGLT2 inhibitor class to be approved in the United States in March 2013 and was approved in the European Union in November last year.

Another agent in the same class, ipragliflozin (Suglat, Astellas Pharma/Kotobuki Pharmaceutical), has just been cleared for marketing in Japan, the first such agent introduced there.


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