US FDA clears Takeda's Edarbi for hypertension and grants full approval for GSK's Promacta

The US Food and Drug Administration on Friday approved Edarbi (azilsartan medoxomil), from Japan’s largest drugmaker Takeda (TSE: 4502), to treat high blood pressure (hypertension) in adults, and also gave full approval for GlaxoSmithKline’s (LSE: GSK) Promacta.

Data from clinical studies showed Edarbi to be more effective in lowering 24-hour blood pressure compared with two other FDA-approved hypertension drugs, Diovan (valsartan) and Benicar (olmesartan), the agency noted. The news came just a day after Takeda filed for approval of an investigational fixed-dose combination of azilsartan medoxomil plus chlorthalidone (CLD) for hypertension. (The Pharma Letter February 25).

“High blood pressure is often called the 'silent killer' because it usually has no symptoms until it causes damage to the body,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Drug Products in the FDA’s Center for Drug Evaluation and Research. “High blood pressure remains inadequately controlled in many people diagnosed with the condition, so having a variety of treatment options is important.”