Hanmi Pharmaceutical said that the Ministry of Food and Drug Safety has approved its Amosartan XQ, the world's first four combination therapy.
The drug, which treats hypertension and hyperlipidemia, combines two hypertension treatments -- amlodipine and losartan – with two dyslipidemia treatments of rosuvastatin and ezetimibe. Hanmi plans to launch the drug next February.
"With the approval of Amosartan XQ, Hanmi has completed a lineup of 18 treatments, including its previous Amosartan lineup -- Amosartan, Amosartan Plus, and Amosartan Q-- and can cover all treatment options for hypertension and dyslipidemia patients," the company said.
Hanmi expects Amosartan XQ to solidify its position in the hypertension market by improving medication compliance and maximizing the therapeutic effect of patients at high risk of cardiovascular disease who need blood pressure and lipid management.
"Amosartan XQ minimizes the physicochemical reaction between each component to secure stability and maintain pharmacokinetic properties," the company said. "At the same time, Hanmi applied its unique and creative formulation technology and know-how, such as making the drug size of Amosartan XQ similar to that of other Amosartan lineup drugs."
The ministry's approval comes after Hanmi proved the drug's safety and efficacy by conducting a phase 3 clinical trial on 145 patients with hypertension and dyslipidemia at 13 local medical institutions.
The company confirmed that Amosartan XQ reduced the average low-density lipoprotein cholesterol change rate by about 59.2 percent compared to the conventional hypertension treatment group taking only amlodipine and losartan. Also, patients taking Amosartan XQ reduced their average systolic blood pressure by about 11.1 mmHg more than the traditional dyslipidemia treatment group receiving losartan, rosuvastatin and ezetimibe.
"The combination treatment for hypertension and dyslipidemia continues to make the most noticeable growth in the antihypertensive drug market," said Park Myung-hee, managing director of the marketing division. "Amosartan XQ offers medical staff the best option for treating hypertension and dyslipidemia and provides excellent therapeutic effects to patients by improving medication compliance."
Hanmi CEO Woo Jong-soo said, "The approval of Hanmi's four combination drug not only means the expansion of our Amosartan family lineup but also serves as an opportunity to inform the world of Korea's competitiveness in pharmaceutical technology."
The company will do its best for sustainable management in which the success of new combination drugs leads to the development of innovative treatments, Woo added.