AZ, BMS diabetes drug has been approved in the EU

Hannah Blake

pharmaphorum

AstraZeneca and Bristol-Myers Squibb have announced that the European Commission has approved forxiga tablets for the treatment of type 2 diabetes in the European Union.

Forxiga (dapagliflozin) is a selective and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2) that works independently of insulin to help remove excess glucose from the body. It is a unique mode of action that has not been seen in any other currently available treatments for type 2 diabetes. Forxiga is also the first medicine in the new SGLT2 class to gain regulatory approval for the treatment of type 2 diabetes.

The once-daily oral medication aims to improve glycaemic control in adult patients with type 2 diabetes. Forxiga is intended to be used alongside diet and exercise in combination with other glucose-lowering medicinal products, including insulin, or as a monotherapy in metformin-intolerant patients.

“We are excited about the approval of FORXIGA in Europe, and the significant advancement it represents for the many millions of European patients with type 2 diabetes who need new options to manage this progressive disease. FORXIGA is an important addition to the growing range of Bristol-Myers Squibb and AstraZeneca diabetes treatments and further demonstrates our commitment to addressing the unmet needs of adults with type 2 diabetes.”

Pascal Soriot, Chief Executive Officer, AstraZeneca.

The European Commission’s approval of Forxiga comes 11 months after US regulators rejected the drug in January 2012, citing concerns about the risk of cancer and liver injury and requested additional clinical data.

AstraZeneca and Bristol-Myers Squibb formed a partnership in 2007. Earlier on this year, Bristol-Myers Squibb completed its acquisition of Amylin Pharmaceuticals, with AstraZeneca buying an equal share. The collaboration focuses on researching, developing and commercialising drugs for type 2 diabetes.

The 14th November 2012 was World Diabetes Day – fellow pharmaceutical companies Sanofi and Boehringer Ingelheim announced their plans to further support the growing global diabetes epidemic.

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