Alteon Inc.'s regulatory approval strategy has been thrown a curve ball by the recommendation of an independent review committee that the company discontinue its Phase III ACTION II trial of Pimagedine in Type II diabetes patients with overt nephropathy. The panel saw an increased incidence of side effects in the trial population (see BioCentury Extra, March 19).

To understand ALTN's NDA strategy, it's necessary to look first at ACTION I, the company's Phase III trial of Pimagedine in Type I diabetics with overt nephropathy.