AstraZeneca seeks new dosages of Atacand Plus approval

Anglo-Swedish drug major AstraZeneca has filed a European decentralized procedure submission seeking approval for two new dose strengths of Atacand Plus, for those hypertensive patients not optimally controlled by monotherapy. The reference member state for the procedure is Sweden, and the submission incorporates data from three studies.

The new strengths of the fixed dose combination Atacand Plus, comprised of candesartan cilexetil and hydrochlorothiazide in doses of 32/12.5mg or 32/25mg, will offer a second line hypertension indication for hypertensive patients who are not optimally controlled. The clinical studies in this submission show that Atacand Plus at these doses is more effective in reducing blood pressure than their monotherapy components taken alone. In addition, the fixed dose of Atacand Plus 32/25mg was more effective than 32/12.5mg in hypertensive patients who had inadequate blood pressure control with candesartan monotherapy.

Hypertension presents an important worldwide public-health challenge because of its prevalence and its associated risks for important cardiovascular and kidney disease, notes AstraZeneca. Worldwide, 7.6 million premature deaths (about 13.5% of the global total) and about 54% of stroke cases and 47% of ischemic heart disease events are attributable to high blood pressure. Hypertension is also a major risk factor for chronic heart failure, it adds.