Dearth Of Clinical Data For Aegerion’s Lomitapide May Sidetrack Advisory Committee Review
This article was originally published in The Pink Sheet Daily
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.
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Aegerion is preparing for an advisory committee meeting after submitting its LDL-C lowering oral drug lomitapide to FDA for patients with homozygous familial hypercholesterolemia. The NDA was submitted ahead of that for Isis/Genzyme’s injectable competitor, mipomersen.
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