Yuhan Corp. said it has developed a combination drug mixed Duowell (telmisartan/rosuvastatin) with amlodipine, for the simultaneous treatment of hypertension and dyslipidemia.
The Ministry of Food and Drug Safety on Tuesday granted sales license to Yuhan for Duowell A (telmisartan/rosuvastatin/amlodipine).
The combo medicine’s telmisartan and amlodipine lower blood pressure while its rosuvastatin treats dyslipidemia by controlling cholesterol levels. As patients can take one pill that contains more than two active substances, they can find it easier to take the drug, the company said.
The ministry recognized Yuhan’s new composition of the ingredients and granted six years for the re-evaluation period. During the period, the company collects data to check the medicine’s safety and efficacy. The re-evaluation period is six years for a novel drug, and four years for an incrementally modified drug (IMD).
Yuhan is a latecomer in the market of combo treatments for hypertension and dyslipidemia.
Samjin Pharmaceutical, Ildong Pharmaceutical, Jeil Pharmaceutical, Ahn-Gook Pharmaceutical, Chong Kun Dang, Daewon Pharmaceutical, and Il-yang Pharmaceutical have already obtained approval for their respective combo medicines. University hospitals such as Seoul National University Hospital are prescribing these combo drugs.
The local drug companies’ rush to develop a combo treatment using three ingredients for hypertension and dyslipidemia stemmed from an increase of patients with both of the diseases.
According to data from the Korean Society of Hypertension, patients with both hypertension and dyslipidemia account for 31.9 percent of all the hypertension patients.
Domestic drugmakers are particularly eager to develop a combo drug with a new composition because such medicine is recognized as an IMD, which is eligible for benefits in drug pricing.