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DEERFIELD, Ill. — Takeda Pharmaceuticals North America Inc. has begun rolling out its hypertension medication EDARBI (azilsartan medoxomil) to U.S. pharmacies.
Takeda said the angiotensin II receptor blocker has been approved by the Food and Drug Administration for the treatment of high blood pressure in adults. The once-daily oral therapy can be taken alone or used in combination with other antihypertensive drugs, according to the pharmaceutical company.
In addition, Takeda announced that the FDA has approved updated product labeling for EDARBI that highlights the connection between lowering blood pressure and the decreased risks of adverse cardiovascular outcomes, including strokes and heart attacks. The company explained that the new label reflects FDA guidance released in March 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," commented Paulos Berhanu, M.D., executive medical director of medical and scientific affairs at Takeda Pharmaceuticals North America. "We are pleased to make available EDARBI, an important new treatment option for patients with hypertension and the health care professionals who treat them."
