Novo's Repaglinide To Be Fast-Tracked In USA

Novo Nordisk has been granted expedited review status for its New DrugApplication from the US regulatory authorities for the oral antidiabetic agent NovoNorm (repaglinide), for the treatment of Type II diabetes.

Marianne Kock, project manager of the NovoNorm team, says that repaglinide, a "prandial glucose regulator" and the first of a whole new class of drugs, is administered at each meal and helps maintain the production of insulin in a pattern which mirrors the body's normal rhythm. She adds that because repaglinide is quickly absorbed, it has a rapid onset of action and is associated with a low incidence of side effects.

In comparison to sulfonylureas, repaglinide has a shorter half life, meaning that it gets absorbed and moves out of the body more rapidly. In addition, it is excreted in the bile which provides an advantage over sulfonylureas in the treatment of elderly diabetics with poor kidney function.