First SGLT2 inhibitor to be approved for marketing anywhere in the world
AstraZeneca and Bristol-Myers Squibb are celebrating the approval of Forxiga in the EU, cementing another pillar of their wide-ranging diabetes collaboration into place.
Forxiga (dapagliflozin) becomes the first drug in the new sodium-glucose cotransporter 2 (SGLT2) inhibitor class to be approved for marketing anywhere in the world, and has been given a green light in the EU as a once-daily treatment for adults with type 2 diabetes.
SGLT2 inhibitors work independently of insulin to help remove excess glucose from the body, a mode of action not shared with any currently available treatments for type 2 diabetes. Rather than increasing the ability of insulin to tackle glucose, the drugs help the kidneys flush it from the body directly.
Commenting on the EU approval, John Wilding, head of the diabetes and endocrinology clinical research unit at University Hospital Aintree in the UK, said: "Many Europeans with type 2 diabetes are not reaching treatment goals, increasing their risk of developing complications, so there is a critical need for new treatments."
Forxiga adds to the classes of drugs already available for people with diabetes, and in addition to improving glucose control also confers additional benefits "such as weight loss and blood pressure lowering", he added.
EU approval should give AZ and BMS first-to-market advantage over other companies developing SGLT2 inhibitors, notably Johnson & Johnson's canagliflozin and Boehringer Ingelheim/Eli Lilly's empagliflozin. Canagliflozin was filed for approval in the US in June, while empagliflozin is scheduled for regulatory submissions during 2013.
However, Forxiga's route to market has not been so straightforward in the US, where earlier this year the FDA issued a complete response letter requesting additional data from ongoing studies to quell concerns of possible liver damage and a potential link with breast and bladder cancer.
Providing the FDA's concerns can be addressed, Forxiga could become a blockbuster for AZ and BMS, according to analysts.
Along with Forxiga, AZ and BMS have collaborated on the development of two other diabetes drugs - Onglyza (saxagliptin) and Kombiglyze (saxagliptin and metfomin) - and recently expanded their alliance after BMS acquired Amylin Pharmaceuticals in a $7bn deal.