Not so fast: FDA tacks 3 more months onto decision date for Calliditas' rare kidney disorder drug

Five months after granting Nefecon priority review, the FDA is extending its PDUFA date from Sept. 15 to Dec. 15, Calliditas announced on Tuesday. The Swiss biotech filed for accelerated approval back in March, based on data from 200 patients in the first part of the Phase III NefIgArd trial who showed a significant reduction in proteinuria, or excessive protein in the urine.