FDA clears Sciele, Novo Nordisk fixed-dose combo type 2 diabetes drug

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Sciele Pharma and Novo Nordisk have reported the FDA has approved their PrandiMet tablets, a fixed-dose combination of the fast-acting secretagogue replaglinide (Prandin) and insulin sensitizer, metformin, for the treatment of type 2 diabetes.

Under a previously announced agreement, Sciele will exclusively market PrandiMet to physicians in the U.S. The Atlanta-based company said it anticipates that PrandiMet will be available to physicians and patients in the U.S. in the second half of 2008.

PrandiMet (repaglinide and metformin HCl) has been approved to lower the blood glucose in adult patients with type 2 diabetes whose hyperglycemia cannot be controlled satisfactorily by meglitinide and/or metformin, according to the companies.

The companies said that PrandiMet is the first and only fixed-dose combination of a fast-acting secretagogue and metformin. The combination of metformin and repaglinide has been shown to safely and effectively reduce hemoglobin A1c levels in the convenience of one pill, said Sciele and the Bagsværd, Denmark-based Novo Nordisk.