CHMP backs pomalidomide, lomitapide

EMA's CHMP backed approval of pomalidomide from Celgene Corp. (NASDAQ:CELG) to treat patients with relapsed and refractory multiple myeloma (MM). The committee approved a risk management plan for the thalidomide analog that requires women of reproductive age to comply with pregnancy testing and contraception requirements. Last February, FDA granted accelerated approval to pomalidomide as Pomalyst (see BioCentury Extra, Feb. 28, 2012).

CHMP also recommended approval of an MAA for Lojuxta lomitapide from Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR) as an adjunct to a low-fat diet and other lipid-lowering therapies with or without LDL apheresis to treat homozygous familial hypercholesterolemia (HoFH) in adults. FDA approved the small molecule microsomal triglyceride transfer protein (MTP) inhibitor as Juxtapid in December (see BioCentury, Feb. 4). ...