Dearth Of Clinical Data For Aegerion’s Lomitapide May Sidetrack Advisory Committee Review

Aegerion submitted the lomitapide NDA Feb. 29 with 54-week data from a single-arm, open-label trial, hoping for priority review based on the lack of effective treatments for homozygous familial hypercholesterolemia. Meanwhile, Isis/Sanofi submitted their competing candidate mipomersen March 29 with two-year extension-study data.