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.

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.

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By GlobalData

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.