European Medicines Agency's (EMA) the Committee for Medicinal Products for Human Use (CHMP) has issued positive opinion for AstraZeneca and Bristol-Myers Squibb's of Xigduo for adults aged 18 and older with type 2 diabetes mellitus.
The drug received positive opinion for treatment of patients with type 2 diabetes as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their current metformin-based treatment regimen or who are currently being treated with the combination of dapgliflozin and metformin as separate tablets.
The twice daily tablet is a combination of dapagliflozin, a selective and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2), and metformin hydrochloride.
According to the company, this is the first CHMP recommendation for a SGLT2 and metformin hydrochloride fixed dosage combination.
The European Commission, which has the authority to approve medicines for the EU, will now review the CHMP's positive opinion and the final decision will be applicable to all 28 EU member countries plus Iceland and Norway.
Xigduo combines Forxiga and metformin hydrochloride, two anti hyperglycaemic products with complementary mechanisms of action to improve glycaemic control.
Forxiga, the first medicine in the SGLT2 class to gain regulatory approval, is currently approved for the treatment of type 2 diabetes in the EU, Argentina, Australia, Brazil, Mexico and New Zealand.
