FDA Advisory Committee Recommends Approval of Aegerion’s Drug - Lomitapide for Treatment of Homozygous Familial Hypercholesterolemia

The FDA Advisory Committee voted 13-2 in favor of approving lomitapide in patients with homozygous familial hypercholesterolemia (HoFH).

HoFH patients have a genetic deficiency that leads to fatal levels of bad cholesterol.

The Advisory Committee is a panel of experts that reviews data concerning the safety and effectiveness of a drug and makes appropriate recommendations to the FDA.

The overwhelmingly positive vote supports the adequacy of efficacy and safety data of lomitapide and validates the benefit of Aegerion’s drug in severe patients.

FDA is not required to follow the advice of the Advisory Committee, though it often does.
FDA plans to complete its review of lomitapide by December 29, 2012.

AEGR stock is up 50% over last 5 days.

Please consult attachment for the full announcement

Aegerion Pharmaceuticals, Inc.

Aegerion Pharmaceuticals, Inc.
Cardiovascular drug development