New three-drug combination drug ‘Amrojet’ obtained approval from the Ministry of Food and Drug Safety
4 capacities… Easy patient-tailored prescription
Expansion of circulatory system treatment portfolio
Domestic market size approximately 200 billion won… 3040 Patient increasing trend
Celltrion Pharmaceuticals announced on the 27th that it has obtained product approval from the Ministry of Food and Drug Safety (MFDS) for ‘Amroset’, a triple drug combination drug for high blood pressure and hyperlipidemia.
Amloget tablet is a three-drug combination drug that combines ‘Amlodipine’, a calcium channel blocker (CCB) class of hypertension treatment, and ‘Rosuvastatin’ and ‘ezetimibe’, a statin/vistatin class hyperlipidemia treatment. The product consists of four doses based on amlodipine, rosuvastatin, and ezetimibe: 10·10·10mg, 10·10·5mg, 10·5·10mg, and 10·5·5mg.
Celltrion Pharmaceutical applied for product approval for Amrozet in May based on the results of phase 3 clinical trials. Through this, it received approval for hypertension and myocardial ischemia, which are indications for amlodipine, and primary hypercholesterolemia, which is an indication for the rosuvastatin and ezetimibe combination drug.
In a phase 3 clinical study conducted on a total of 163 patients with hypertension and hyperlipidemia at 21 domestic institutions, Amroset reduced primary hypercholesterolemia compared to the control group rosuvastatin and ezetimibe (or amlodipine). It was proven to be superior in improving lipid factors (LDL-C) and blood pressure (MSSBP) in patients with essential hypertension.
The domestic hypertension and hyperlipidemia combination drug market is known to be worth about 200 billion won as of last year. Recently, the number of patients in their 30s and 40s has been increasing significantly due to changes in eating habits. The size of the hypertension and hyperlipidemia treatment market is expected to follow a similar trend.
An official from Celltrion Pharmaceutical said, “Through this product approval, we have established a diverse portfolio of circulatory systems,” and added, “We will do our best to improve medication compliance for patients suffering from hypertension and hyperlipidemia and provide diverse treatment options to enable early entry into the combination drug market.” “It is,” he said.
Kim Min-beom, Donga.comreporter [email protected]
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