8-Nov-10 2:00 PM  CST

New Diabetes Drug Combo FDA-Approved

The FDA has approved a first-of-its-kind combination drug in the United States to help treat type 2 diabetes, drugmakers AstraZeneca and Bristol-Myers Squibb announced last Friday.
Kombiglyze XR is a combination of extended release metformin with the relatively new dipeptidyl peptidase-4 (DPP-4) inhibitor Onglyza (saxagliptin). It will be available in 5 mg/500 mg, 5 mg/1000 mg, 2.5 mg/1000 mg extended release, once-a-day tablets to help patients with type 2 diabetes control their glucose levels.
“Patients with type 2 diabetes in the United States can be taking four or five medications for various diseases and conditions, which can lead to complicated medication schedules,” said Howard Hutchinson, M.D., chief medical officer, AstraZeneca, in a joint statement by AstraZeneca and Bristol-Meyers Squibb. “Kombiglyze XR combines two effective diabetes medications in a simple once-a-day dose for adult patients who need A1c reductions.”
Onglyza is jointly manufactured by Bristol-Myers Squibb and AstraZeneca. It was FDA-approved back in July 2009 and is the most recently approved medication in a drug class called dipeptidyl peptidase-4 (DPP-4) inhibitors. DPP-4 inhibitors work to lower glucose levels by stimulating insulin production and decreasing the amount of glucagon released from the pancreas. Kombiglyze marks the first time a DPP-4 inhibitor has ever been FDA-approved in a combination form with metformin.
Reported side effects for Kombiglyze include diarrhea, nausea, headache, upper respiratory tract infection and urinary tract infection. The drug also carries a warning for a rare metabolic condition called lactic acidosis, which can occur from metformin accumulation. More information on Kombiglyze, including lists of side effects and drug interactions, is available on the news release issued by Bristol-Myers Squibb and AstraZeneca.
A representative from AstraZeneca said Kombiglyze is expected to be available in the U.S. in the coming weeks.
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