Lojuxta lomitapide regulatory update

The European Commission approved an MAA from Aegerion for Lojuxta lomitapide to treat homozygous familial hypercholesterolemia (hoFH). Aegerion said it plans to launch the product "as swiftly as possible." The small molecule microsomal triglyceride transfer protein (MTP) inhibitor is indicated as an adjunct to a low-fat diet and other lipid-lowering therapies with or without LDL apheresis. The approval includes a risk management plan to educate physicians on safety information for the drug, along with precautions for healthcare professionals and patients. Aegerion will also conduct an observational postmarketing study on long-term safety, long-term effectiveness of controlling LDL-C levels and compliance. EMA's CHMP issued a positive opinion recommending approval of the MAA in May (see BioCentury, June 3). ...