UK's NICE backs NHS use of Bristol-Myers/AstraZeneca's Forxiga

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) today (May 30) issued a Final Appraisal Determination (FAD) for drug majors Bristol-Myers Squibb (NYSE: BMY) and AstraZeneca’s (LSE: AZN), first-in-class type 2 diabetes medicine Forxiga (dapagliflozin)., recommending use of the drug as a treatment option for adults with type 2 diabetes as dual therapy in combination with metformin, and in combination with insulin with or without other oral antidiabetic drugs.

The FAD recommends dapagliflozin to be used in combination with metformin instead of a sulphonylurea (SU) in certain patients. These are patients for whom an SU is not tolerated/contraindicated or are at significant risk of hypoglycaemia or its consequences. Furthermore, the addition of dapagliflozin to metformin may be preferable to a thiazolidinedione if further weight gain is a concern. This is in line with NICE guidance CG87 in relation to the use of dipeptidyl peptidase-4 (DPP-4) inhibitors in dual therapy with metformin. 3

The FAD, which will form the basis of final NICE guidance, follows Marketing Authorization issued on November 14, 2012, by the European Medicines Agency and advice from the Scottish Medicines Consortium on January 14, 2013. The NICE recommendation means that adults with type 2 diabetes who are not being managed on metformin alone or insulin will soon have access to this new, cost-effective oral once-daily, first-in-class treatment.