The European Commission has granted marketing authorisation to AstraZeneca and Bristol-Myers Squibb‘s (BMS’s) Xigduo (dapagliflozin and metformin hydrochloride in 5mg/850mg and 5mg/1,000mg tablets) for the treatment of type 2 diabetes in the European Union (EU).

The twice daily tablet, Xigduo is a combination of dapagliflozin (trade name Forxiga), a selective and reversible inhibitor of SGLT2, and metformin hydrochloride.

Dapagliflozin and metformin hydrochloride are two anti-hyperglycaemic products with complementary mechanisms of action to improve glycaemic control.

Regulatory approval for Xigduo is claimed to be the first for a fixed dose combination of an SGLT2 inhibitor and metformin.

"We now have an SGLT2 inhibitor and metformin combination product representing an innovative option for treating adults with type 2 diabetes."

The drug is indicated for adults aged 18 and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control.

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Xigduo is indicated in patients inadequately controlled on their current metformin-based treatment regimen or who are currently being treated with the combination of dapagliflozin and metformin as separate tablets.

Forxiga was the first medicine in the SGLT2 class to gain regulatory approval, which received marketing authorisation in the EU for type 2 diabetes in November 2012, and is currently approved for the treatment of type 2 diabetes in 40 countries, including the US (under the trade name Farxiga) and Australia.

AstraZeneca vice-president Elisabeth Björk said Xigduo will help patients manage glycaemic control.

"We recognise that not all patients are alike and that different treatments are needed, supporting a more personalised approach to disease management," Björk said.

"Metformin has long been a standard of diabetes care, and with the Xigduo approval, we now have an SGLT2 inhibitor and metformin combination product representing an innovative option for treating adults with type 2 diabetes."

SGLT2 is a sodium-glucose cotransporter found predominantly in the kidney and is responsible for the majority of glucose reabsorption.

In type 2 diabetic patients, the capacity of the kidney to reabsorb glucose is increased by about 20%, further exacerbating the hyperglycaemia associated with the disease.

AstraZeneca and Bristol-Myers Squibb have earlier signed an agreement, pursuant to which, AstraZeneca will acquire the entirety of Bristol-Myers Squibb’s interests in the companies’ diabetes alliance to consolidate worldwide ownership of the diabetes business within AstraZeneca.