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Takeda files combination blood pressure drug

Takeda has submitted a new drug application to the US Food and Drug Administration for an investigational combination therapy for high blood pressure

Takeda Pharmaceutical has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for an investigational new combination therapy for high blood pressure.

The product is a fixed-dose combination of an angiotensin II receptor blocker (ARB) discovered by Takeda called azilsartan medoxomil plus chlorthalidone, a long-acting diuretic that is available as a generic from a number of manufacturers. It is the first combination of chlorthalidone and an ARB to be submitted for marketing in the US.

The NDA contains data from four phase III trials that enrolled a total of more than 4,000 hypertension patients. In one of the trials, the combination product was studied versus azilsartan medoxomil and chlorthalidone monotherapies.

In other studies, the combination was compared to azilsartan medoxomil co-administered with the generic diuretic hydrochlorothiazide and with a fixed-dose combination of Daiichi Sankyo's Benicar (olmesartan) and hydrochlorothiazide.

Takeda submitted a US marketing application for azilsartan medoxomil as a monotherapy for hypertension in late April and is still awaiting a decision on that submission.

Phase III clinical studies of azilsartan medoxomil on its own found that it was more effective at lowering blood pressure than Novartis' Diovan (valsartan) or Benicar. Analysts polled by Thomson Reuters predicted the Takeda drug could have annual sales of $733m in 2014.

24th February 2011

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