Drugs Xagena
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Lojuxta, 5mg, 10mg, 20mg hard capsules intended as an adjunct to a low fat diet and other lipid lowering medicinal products with or without low density lipoprotein ( LDL ) apheresis in adult patients with homozygous familial hypercholesterolaemia ( HoFH ).
The active substance of Lojuxta is Lomitapide, other lipid modifying agents, plain and is a selective inhibitor of microsomal transfer protein ( MTP ), an intracellular lipid-transfer protein responsible for binding and shuttling lipids between membranes. MTP plays a key role in the assembly of apo B containing lipoproteins in the liver and intestines. Inhibition of MTP reduces lipoprotein secretion and circulating concentrations of lipoprotein-borne lipids including cholesterol and triglycerides.
The benefits with Lojuxta are its ability to consistently reduce LDL-cholesterol levels by approximately 40% in HoFH patients.
The most common side effects are gastrointestinal and hepatic adverse events, is some cases leading to treatment discontinuation; weight loss has also been observed.
A pharmacovigilance plan for Lojuxta will be implemented as part of the marketing authorisation.
The approved indication is: Lojuxta is indicated as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein ( LDL ) apheresis in adult patients with homozygous familial hypercholesterolaemia ( HoFH ). Genetic confirmation of HoFH should be obtained whenever possible. Other forms of primary hyperlipoproteinemia and secondary causes of hypercholesterolemia ( e.g., nephrotic syndrome, hypothyroidism ) must be excluded.
It is proposed that treatment with Lojuxta should be initiated and monitored by a physician experienced in the treatment of lipid disorders. ( Xagena )
Source: European Medicines Agency, 2013
XagenaMedicine_2013
