The European Commission has approved a label extension for Bristol-Myers Squibb and partner AstraZeneca’s type 2 diabetes drug Onglyza® (saxagliptin), covering use of a once-daily 2.5 mg dose for the treatment of adult type 2 diabetes patients who have moderate-to-severe renal impairment. The firms say that Onglyza is the first dipeptidyl peptidase-4 (DPP-4) inhibitor licensed in the EU for this specific indication.
The new approval was granted on the basis of a 12-week study comparing Onglyza with placebo in 170 patients with type 2 diabetes and renal impairment. 98.2% of patients included were already being treated with other antihyperglycemic medications.
European clearance follows FDA confirmation just last month that it had approved the inclusion of data from clinical studies evaluating Onglyza in renal impairment patients to the drug’s prescribing information. The prescribed dose of Onglyza is 2.5 mg once daily for patients with moderate or severe renal impairment, or with end-stage renal disease requiring hemodialysis.
Onglyza is already licensed in 56 countries as once-daily combination therapy with either metformin, sulphonylurea, or thiazolidinedione, for improving glycemic control in adult type 2 diabetes patients whose disease is not adequately managed through treatment with any of the former three drugs combined with diet and exercise. Kombiglyze XR, an extended-release tablet combining saxagliptin and metformin, was approved in the U.S. in 2010. The combination therapy has also been submitted to the European regulatory authorities.
BMS and AstraZeneca teamed up back in 2007 for the worldwide (excluding Japan) development and commercialization of the U.S. firm’s type 2 diabetes candidates saxagliptin and dapagliflozin, a sodium-glucose co-transporter-2 (SGLT2) inhibitor. Terms of the deal included a $100 million up-front payment to BMS by AstraZeneca, and the latter was also to shoulder the majority of development costs for the two candidates for the first two years. A year later the firms expanded their agreement to cover development of dapagliflozin in Japan as well.
Reporting on its fourth quarter 2010 results back in January, BMS confirmed that in December the two partners had submitted both U.S. and EU regulatory filings for approval of dapagliflozin as a once-daily oral therapy for the treatment of adult patients with type 2 diabetes. In a pipeline update in January AstraZeneca projected filing for approval of a dapagliflozin and metformin combination therapy in the U.S. and Europe during the first half of 2012.