US FDA approves Novartis' Amturnide for BP and Watson's chewable oral contraceptive, but delays Alimera's Iluvien

In a flurry of year-end activity, the US Food and Drug Administration yesterday approved Swiss drug major Novartis’ (NOVN: VX) Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets for the treatment of high blood pressure as well as Watson Pharmaceuticals’ (NYSE: WPI) new chewable oral contraceptive. But it also issued a complete response letter delaying the approval of Alimera Sciences’ (Nasdaq: ALIM) ophthalmic product Iluvien (fluocinolone acetonide intravitreal insert).

Amturnide combines the only approved direct renin inhibitor worldwide, Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide. The FDA approval was based on data from a double-blind, active controlled study, which showed that Amturnide provided significantly greater reductions in blood pressure compared to all dual combinations of its components. The drug is approved for patients whose blood pressure is not adequately controlled with any two of its individual components and is not indicated as initial therapy for high blood pressure. Amturnide is only the third high blood pressure treatment to combine three drugs in a single-pill, the company noted.

"The FDA approval of Amturnide provides an important treatment option to help address the complex needs of high blood pressure patients," said Andre Wyss, president of Novartis Pharmaceuticals in the USA, adding: "This approval emphasizes our commitment to cardiovascular research and to developing innovative and effective treatments for patients who have not reached their blood pressure goal."