Regulators in the USA have given the green light to Bristol-Myers Squibb and AstraZeneca's diabetes combination treatment Kombiglyze XR.
The US Food and Drug Administration has approved the pill, which combines the firms' diabetes drug Onglyza (saxagliptin) with metformin. B-MS noted that Kombiglyze is "the first and only once-a-day metformin extended-release plus DPP-4 inhibitor combination tablet."
The approval was based on two Phase III trials. In one 24-week study involving 1,306 treatment-naive adults with type 2 diabetes, those on Kombiglyze had significant reductions in HbA1c levels of -2.5%, compared to -2.0% with immediate-release metformin plus placebo.
In a second 24-week 743-patient study, those on the combo experienced a HbA1c of -0.7% compared to an increase of 0.1% in patients taking immediate-release metformin plus placebo. In both studies, Kombiglyze led to significant reductions in fasting plasma glucose and post-prandial glucose levels.
B-MS R&D head Elliot Sigal said that nearly half of adults remain uncontrolled on their current treatment regimen "and may thus require additional medications". He added that “with our heritage of bringing metformin", the most widely-prescribed oral antidiabetic, "and more recently saxagliptin to patients in the USA, we are committed to making Kombiglyze XR the newest building block" in diabetes treatments.
AstraZeneca's chief medical officer Howard Hutchinson noted that patients can be taking four or five medications for various diseases and conditions, "which can lead to complicated medication schedules.” Given this, analysts believe that a simple once-a-day dose for adults who need A1c reductions has a place in the market, especially as Merck & Co's Janumet, combining Januvia (sitagliptin) and metformin is taken twice-daily. The Merck combo had third-quarter sales of $247 million, up 43%.