Hanmi Expands Lineup of New Antihypertensive Drugs Based on Approval of Closartan
On June 2, Hanmi Pharmaceutical (co-CEOs Woo Jong-soo and Kwon Se-chang) announced that it had obtained marketing approval from the Ministry of Food and Drug Safety for Closartan Tab (two doses: 50/12.5mg and 100/12.5mg). Closartan Tab is an antihypertensive drug combining losartan, an angiotensin II receptor blocker (ARB), and chlorthalidone, a thiazide-like diuretic.
Hanmi Pharm explained that it had developed Closartan specifically for high blood pressure patients whose blood pressure could not be properly controlled with losartan alone. By combining it with chlorthalidone, it can reduce blood pressure more effectively than the combination drug composed of losartan and hydrochlorothiazide.
Chlorthalidone is recommended with precedence among all diuretics in the hypertension guidelines. Various clinical studies have shown that it is more effective in lowering blood pressure, reducing the risk of cardiovascular disease, and lowering nocturnal blood pressure based on a longer half-life compared to hydrochlorothiazide.
Hanmi Pharm proved the superior antihypertensie effect of Closartan compared to losartan monotherapy through two Phase 3 clinical trials (CHORUS-301 and CHORUS-302). In these trials, they rounded up patients whose blood pressure could not be controlled with losartan monotherapy, and divided into two groups: Closartan dose group and losartan monotherapy group. After an 8-week comparative clinical study, it has demonstrated the efficacy and safety of the new drug.
Professor Kang Seok-min (Department of Cardiology, Yonsei University Severance Hospital), the principal investigator in the two clinical trials, said, “Closartan is a fixed-dose combination drug demonstrating the excellence of chlorthalidone, which has superior half-life and cardiovascular protection effect compared to hydrochlorothiazide. […] Considering there is a buildup of research results showing that losartan offsets possible adverse reactions from using chlorthalidone, Closartan (losartan + chlorthalidone) is an excellent treatment that can be prescribed to patients whose blood pressure cannot be controlled by monotherapy.”
Professor Kang added, “The two clinical trials are significant in that they provided evidence for the powerful blood pressure lowering effect of Closartan in patients whose blood pressure was not controlled with losartan monotherapy. […] Closartan, which has excellent blood pressure lowering effect and the effect of reducing the risk of cardiovascular disease, is expected to be a useful treatment option in the medical setting.”
An official from Hanmi Pharmaceutical said, “With the launch of Closartan, healthcare professionals in the clinical setting have a wider range of options, and it is possible to offer customized treatment for diverse high blood pressure patients. […] We will do our best to present useful research results to healthcare professionals through ceaseless R&D efforts and release new products that can be helpful in the actual clinical setting.”
Source: Uihak Sinmun (Medical Newspaper)