AstraZeneca and Bristol-Myers get first approval for diabetes drug Forxiga

There was good news for AstraZeneca (LSE: AZN) and Bristol-Myers Squibb (NYSE: BMY), with the European Commission approval of Forxiga (dapagliflozin) tablets for the treatment of type 2 diabetes in the European Union.

This is the first medicine in the new SGLT2 class to gain regulatory approval for the treatment of type 2 diabetes, a disease in which high unmet medical need exists, the companies noted. Dapagliflozin is awaiting approval in the USA, where the Food and Drug Administration earlier this year issued a complete response letter requesting additional data.

Forxiga will join a type 2 diabetes drug market is expected to nearly double over the next decade, increasing from $26 billion in 2011 to nearly $50 billion in 2021 in the USA, France, Germany, Italy, Spain, the UK and Japan, according to a new report from Decision Resources. (The Pharma Letter October 16). SGLT-2 inhibitors are viewed as the most interesting agents, most notably AstraZeneca/Bristol-Myers Squibb’s dapagliflozin and Johnson & Johnson’s canagliflozin, which are expected to have an impact on the treatment paradigm for type 2 diabetes, the report said.