Aegerion Pharmaceuticals Inc (fka AEGR)

[mlkrborn]

Aegerion Pharma announces Lomitapide 78-week Phase III clinical data consistent with earlier results; efficacy and safety profile maintained (AEGR) 16.14 +0.38 : Co reported that the 78-week data from its pivotal Phase III clinical trial are consistent with data previously reported at the 26- and 56-week time points. The Phase III study was a single-arm, open label trial, designed to evaluate the efficacy and long-term safety of lomitapide for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). The data demonstrate that the reduction in LDL-C cholesterol from baseline was maintained at 78-weeks. Mild-to-moderate gastrointestinal adverse events have been the most commonly reported side effect in this trial. The frequency of these events decreased after the dose escalation period was finished and patients were established on their maximum tolerated dose.