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

This article was originally published in The Pink Sheet Daily

Executive Summary

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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