FDA Panel Backs Novo's Repaglinide

Novo Nordisk's type 2 diabetes drug Prandin (repaglinide) should beapproved for marketing in the USA, according to the US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee.

The panel voted eight to one to approve repaglinide, which represents a completely new approach to treating type 2 diabetes. It is a benzoic acid derivative, acting via calcium channels to regulate insulin secretion and post-prandial glucose levels.

Unlike other oral hypoglycemic agents, it has a short half-life, so is theoretically less likely to cause hypoglycemic episodes, although this has not been shown clinically as Novo's trials of the agents, involving 2,200 patients had a very low rate of these episodes, both for repaglinide and comparator sulfonylureas. Another key benefit is that patients need only remember to take one tablet before a meal.