AstraZeneca and Bristol-Myers Squibb are celebrating following the approval of their diabetes drug Forxiga in the European Union.
Forxiga 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. The companies noted that this is the first medicine in the SGLT2 class to gain regulatory approval for the treatment of type 2 diabetes.
The once-daily tablet is intended to be used as an adjunct to diet and exercise in combination with other glucose-lowering medicinal products, including insulin, or as a monotherapy in metformin-intolerant patients. AZ and B-MS noted that in clinical studies, Forxiga also showed reductions in weight and blood pressure.
The companies quoted John Wilding of the University Hospital Aintree, UK as saying that 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". He added that Forxiga "provides physicians with a completely new option to help improve glycaemic control that complements commonly used glucose-lowering treatments like metformin and insulin with additional benefits of weight loss and blood pressure lowering".
Back in May, the Committee for Medicinal Products for Human Use of the European Medicines Agency published a positive opinion on Forxiga. However, earlier this year, the US Food and Drug Administration issued a complete response letter for the drug and requested additional data from ongoing studies amid concerns of possible liver damage and a potential link with breast and bladder cancer.