AstraZeneca Plc (AZN.L, AZN) and Bristol-Myers Squibb Co. (BMY) announced that Xigduo (dapagliflozin and metformin hydrochloride in 5mg/850mg and 5mg/1000mg tablets) has been granted Marketing Authorisation by the European Commission for the treatment of type 2 diabetes in the European Union or EU.
Xigduo combines dapagliflozin (trade name Forxiga), a selective and reversible inhibitor of SGLT2 with metformin hydrochloride, two anti-hyperglycaemic products with complementary mechanisms of action to improve glycaemic control, in a twice daily tablet. This is the first regulatory approval for a fixed dose combination of an SGLT2 inhibitor and metformin, the company said.
Xigduo is indicated for adults aged 18 and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control. It 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, having 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 United States (available under the trade name Farxiga) and Australia.
On 19 December 2013, AstraZeneca and Bristol-Myers Squibb announced an agreement under 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. The closing of the transactions contemplated by the agreement is subject to customary terms and conditions, and is expected to occur during the first quarter of 2014.
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