The FDA has approved azilsartan medoxomil (Edarbi), an oral angiotensin II receptor blocker (ARB) for hypertension, expanding the ranks of ARBs now available to U.S. patients.
According to the FDA, the newly approved agent was more effective in clinical studies than two other FDA-approved ARBs, valsartan (Diovan) and olmesartan (Benicar).
Azilsartan medoxomil, formerly known as TAK-491, is manufactured by Takeda Pharmaceutical's U.S. arm, based in Deerfield, Ill.
The FDA said adverse events reported in clinical trials with the drug were similar to those seen with placebo.
The drug will be available in 80- and 40-mg doses, with the recommended dose set at 80 mg once daily, the FDA said. The 40-mg dose will be available for patients who are treated with high-dose diuretics.
Takeda is also developing a combination product that includes the diuretic chlorthalidone along with azilsartan medoxomil. On Thursday, the company said it had filed a marketing application with the FDA for the combination product.
Its application for azilsartan medoxomil as monotherapy was supported by seven phase III studies enrolling more than 5,900 patients, the company said.
In one of the studies, a 24-week randomized trial pitting the drug against valsartan in some 650 patients, azilsartan medoxomil lowered 24-hour mean systolic pressure by about 15 mm Hg, compared with 11.3 mm Hg for valsartan at 320 mg/day. A similar difference was seen in trough measurements of systolic pressure.
Azilsartan medoxomil is actually a prodrug for the active compound, which is currently in development outside the U.S. as a separate product, a company spokeswoman said.