FDA approves Takeda antihypertensive

The US Food and Drug Administration (FDA) has approved Takeda's Edarbi tablets (azilsartan medoxomil) to treat high blood pressure in adults, either as monotherapy or in combination with other antihypertensives.

Phase III clinical studies of the angiotensin II receptor blocker (ARB) found that it was more effective at lowering blood pressure than the highest approved doses of Novartis' Diovan (valsartan) or Daiichi Sankyo's Benicar (olemesartan). Analysts polled by Thomson Reuters predicted the Takeda drug could have annual sales of $733m in 2014.

Edarbi will be available in 80mg and 40mg doses, with the recommended dose set at 80mg once daily. The 40mg dose will be sold for patients who are treated with high-dose diuretics taken to reduce salt in the body.

The drug will carry a boxed warning, which is the strongest warning that the FDA can require, stating that it should not be taken during pregnancy because use during the second or third trimester can cause foetal injury or death.

Takeda submitted the US new drug application for Edarbi in April 2010. This month, the company submitted an additional application to the FDA for a fixed-dose combination of Edarbi plus chlorthalidone, a long-acting diuretic that is available as a generic from a number of manufacturers. The product is the first combination of chlorthalidone and an ARB to be submitted for marketing in the US.