Takeda files NDA for azilsartan medoxomil in USA, settles Actos patent disputes; Actavis debuts generic Flomax

Leading Japanese drugmaker Takeda Pharmaceutical says that Takeda Global Research & Development Center, USA, has submitted a New Drug Application to the Food and Drug Administration for azilsartan medoxomil (TAK-491), an angiotensin II receptor blocker under investigation for the treatment of hypertension. Discovered by Takeda, the compound is designed to lower blood pressure by blocking the action of angiotensin II.

"The NDA submission for azilsartan medoxomil is built upon a robust data package and is a significant milestone for Takeda," said Nancy Joseph-Ridge, general manager of Takeda's Pharmaceutical Development Division. The company is looking to replace its current blockbuster antihypertensive Blopress (candesartan cilexetil), which will lose US patent protection in 2012.

The NDA submission was supported by seven Phase III clinical trials involving more than 5,900 patients. The safety and efficacy of azilsartan medoxomil was studied for initial therapy as a once-daily oral monotherapy or in combination with other antihypertensive medications, including chlorthalidone and amlodipine, and was also studied in comparison to olmesartan medoxomil, valsartan and ramipril. Results from five of the pivotal Phase III studies will be presented May 1-4, at the American Society of Hypertension 25th Annual Scientific Meeting and Exposition in New York.