FDA Approves Hypertension Medication


April 21, 2011

April 21, 2011 – A new angiotensin II receptor blocker (ARB) has been approved by the U.S. Food and Drug Administration (FDA) to treat hypertension, or high blood pressure. Edarbi (azilsartan medoxomil), by Takeda Pharmaceutical Company, is now available by prescription for adults in U.S. pharmacies. Edarbi is a once-daily oral therapy for use alone and for use in combination with other antihypertensive medications.


Pivotal phase 3 studies showed it (80 mg/day) was statistically superior to the highest approved doses of two commonly prescribed ARBs, olmesartan medoxomil (40 mg/day) and valsartan (320 mg/day) in lowering both clinic systolic blood pressure (SBP) and 24-hour mean SBP as measured by Ambulatory Blood Pressure Monitoring (ABPM). The FDA also approved updated product labeling for Edarbi, which highlights the connection between lowering blood pressure and decreased risks of cardiovascular outcomes, including strokes and heart attacks. The new product label reflects FDA guidance released in March 2011 for manufacturers of all antihypertensive treatments.


The guidance stated, "blood pressure control is well established as beneficial in preventing serious cardiovascular events, and inadequate treatment of hypertension is acknowledged as a significant public health problem."


"Hypertension is a serious condition but typically does not have any symptoms, and many aren't aware of the long-term impact hypertension has on cardiovascular health," said Paulos Berhanu, M.D., executive medical director of medical and scientific affairs, Takeda Pharmaceuticals North America. "We are pleased to make available Edarbi, an important new treatment option for patients with hypertension and the healthcare professionals who treat them."


For more information: www.takeda.com