US-based Organon (NYSE: OGN) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Liptruzet (ezetimibe, atorvastatin), which is indicated for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH) in China.
DYSIS China Study and Liptruzet’s Impact
The DYSIS China study reveals that among Chinese patients with dyslipidemia who have undergone routine lipid-lowering therapy for three months, the compliance rate for secondary prevention of LDL-C is a concerning 33.09%, with extremely high-risk patients faring even worse at 26.86%. Liptruzet, by inhibiting hydroxymethylglutaryl coenzyme A reductase, can reduce cholesterol synthesis in the liver and selectively inhibit the cholesterol transporter in the small intestine, thereby reducing cholesterol absorption. The combination of ezetimibe and atorvastatin in Liptruzet offers new options for the treatment of atherosclerotic cardiovascular diseases.
Liptruzet’s Global Approvals and Relevance
Liptruzet was first approved in the US in 2013 for treating elevated LDL-C levels in patients with primary or mixed hyperlipidemia and for reducing cholesterol levels in HoFH patients. It later received approval in the European Union in 2016 to reduce the risk of cardiovascular events in patients with coronary heart disease and acute coronary syndrome, regardless of prior statin treatment. In China, Liptruzet joins Amgen’s Repatha (evolocumab), a PCSK9 inhibitor included in the National Reimbursement Drug List (NRDL), as a treatment option for HoFH.-Fineline Info & Tech
