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

Latest News

Clinical study supports the use of Cheetah Medical's technologies

Cheetah Medical, a leader in non-invasive hemodynamic monitoring, has announced the publication of a major clinical study designed to evaluate stroke volume guided resuscitation in ICU patients with severe sepsis and septic shock

Vertos Medical Secures $28m in Latest Round of Funding

Vertos Medical Inc., a leader in the minimally invasive treatment of lumbar spinal stenosis has announced that it has completed a $28 million financing round.

VitalConnect Announces Closure of $33m Series C Financing

VitalConnect, a leader in medical-grade wearable biosensor systems, has announced that it has closed a Series C Preferred Stock equity financing round of $33 million led by new investors MVM Life Science Partners and Baxter.

Providence Medical Technology announces new equity financing of $10.5 million

Providence Medical Technology, Inc., an innovator in tissue-sparing, cervical-fusion technology, has announced the closing of $10.5 million in new equity financing for the company.

Wilson Therapeutics announces that WTX101 meets the primary endpoint in Phase 2 study in Wilson Disease

Wilson Therapeutics AB has announced that the Phase II study of WTX101 (bis-choline tetrathiomolybdate; Decuperate®), an investigational first in class copper modulating agent with a unique mode of action for the treatment of patients with Wilson Disease, met its primary endpoint.

MVM invests €15.2m in Valneva SE

Valneva SE is a commercial stage vaccine company with products to prevent Japanese encephalitis and cholera