Takeda Pharmaceutical Co is celebrating after getting the green light from the US Food and Drug Administration for its new blood pressure drug Edarbi.
Specifically, the agency has approved Edarbi (azilsartan medoxomil), an angiotensin II receptor blocker, as a once-daily oral therapy for hypertension. The thumbs-up is based on seven Phase III trials involving 5,900 patients which showed its superiority to placebo and the highest approved doses of two commonly-prescribed ARBs, Daiichi Sankyo's Benicar (olmesartan) and Novartis' Diovan (valsartan) in lowering blood pressure.
The FDA has demanded a boxed warning that says Edarbi should be avoided in pregnant women as use during the second or third trimester can cause injury and even death in the developing foetus. However, Norman Stockbridge, director of the Division of Cardiovascular and Renal Drug Products in the FDA’s Center for Drug Evaluation and Research, noted that "high blood pressure remains inadequately controlled in many people diagnosed with the condition, so having a variety of treatment options is important.".