Celltrion Pharm secures permit for 3-combo hypertension and dyslipidemia drug

Celltrion Pharm said it has received approval from the Ministry of Food and Drug Safety for its triple-combination drug, Amlorzet, designed to treat hypertension and dyslipidemia.

Amlorzet is a fixed-dose combination drug comprising three key active ingredients -- amlodipine, a calcium channel blocker (CCB) for hypertension, rosuvastatin, a statin for dyslipidemia, and ezetimibe, a lipid-lowering agent.

The company submitted the marketing application for Amlorzet in May, following a successful phase 3 clinical trial. The drug received approval for the indications of hypertension and myocardial ischemia related to amlodipine, as well as primary hypercholesterolemia for the rosuvastatin-ezetimibe combination.

The phase 3 trial, conducted across 21 medical institutions in Korea, evaluated Amlorzet's efficacy and safety in 163 patients with both hypertension and dyslipidemia.

Results demonstrated that Amlorzet outperformed comparator groups—rosuvastatin plus ezetimibe or amlodipine monotherapy—in reducing both low-density lipoprotein cholesterol (LDL-C) and mean sitting systolic blood pressure (MSSBP) in patients with primary hypercholesterolemia and essential hypertension.

The domestic market for combination therapies addressing hypertension and dyslipidemia was estimated at 200 billion won($143.5 million) in 2023.

Celltrion Pharm expects that the increasing prevalence of these conditions among younger patients, particularly in their 30s and 40s, due to shifting dietary habits and lifestyles, will drive further market expansion.

“The approval of Amlorzet significantly broadens our cardiovascular portfolio,” a Celltrion Pharm official said. “We aim to enhance medication adherence for patients suffering from hypertension and dyslipidemia while offering diverse treatment options.”

With this launch, the company plans to accelerate the early establishment of Amlorzet in the combination therapy market, he added.