FDA approves Juxtapid (Aegerion Pharma) for patients with Homozygous Familial Hypercholesterolemia
The FDA has approved Juxtapid (lomitapide), from Aegerion Pharma, as an adjunct to diet and other lipid-lowering treatments to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B) and non-high-density-lipoprotein cholesterol (non-HDL) in patients with Homozygous Familial Hypercholesterolemia (HoFH). The FDA based its approval on a pivotal Phase III study, which evaluated the safety and effectiveness of the medicine to reduce LDL-C levels in 29 adult patients with HoFH. The study showed the drug significantly reduced LDL-C by 40% at Week 26 in the intent-to-treat population. LDL-C was reduced by an average of 50% for the 23 patients who completed the study through Week 26. After Week 26, during the safety phase of the study, adjustments to concomitant lipid-lowering treatments were allowed. Average reductions in LDL-C were sustained during chronic therapy.
Related news and insights
Zai Lab Limited and its partner Entasis Therapeutics Holdings Inc. announced topline results from the ATTACK trial, a global Phase III registrational trial evaluating the safety and efficacy of SUL-DUR versus colistin in patients with infections caused by Acinetobacter baumannii.
Oyster Point Pharma, Inc. announced that the FDA has approved Tyrvaya (varenicline solution) Nasal Spray 0.03 mg for the treatment of the signs and symptoms of dry eye disease.