Edarbi tablets (azilsartan medoxomil) for the treatment of high blood pressure (hypertension) in adults has been approved by the Food and Drug Administration (FDA), USA. The FDA says it approved Edarbi after examining data from clinical studies which clearly demonstrated Edarbi’s superior efficacy compared to two already FDA-approved medications – Benicar (olmesartan) and Diovan (valsartan).
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 explained that a considerable number of individuals with hypertension have no symptoms until damage to the body occurs, hence its “silent killer” nickname.
“High blood pressure remains inadequately controlled in many people diagnosed with the condition, so having a variety of treatment options is important.”
Edarbi’s recommended dose will be set at 80mg once a day, and will be available in 80mg and 40mg doses. The lower dosage will be for those who are taking high-dose diuretics to lower their levels of salt.
Blood pressure refers to the force of blood pressing against the artery walls as the heart pumps. Sustained high blood pressure can eventually damage the human body. According to the FDA, approximately 30% of the American adult population suffers from high blood pressure – a total of 75 million people. These people have a significantly higher risk of having a heart attack, kidney failure, heart failure, stroke, and dying early.
Nearly one billion people are estimated to have hypertension worldwide. Experts say this figure will probably reach 1.5 billion within the next fifteen years.
Edarbi blocks the action of angiotensin II, a vasopressor hormone – it is an ARB (angiotensin II receptor blocker). Angiotensin II exists naturally in the body. A vasopressor is something that makes the blood vessels contract.
Side effects experienced by patients taking Edarbi in clinical studies were no different from those in the control group (on a placebo).
There is a boxed warning explaining that pregnant women should not take Edarbi – there is a risk of injury and death in the developing fetus during the second and third trimesters. Any female patient on Edarbi who becomes pregnant should stop taking it immediately and tell her doctor.
Shinji Honda, president and CEO, Takeda Pharmaceuticals North America, the makers of Edarbi, said:
“We are pleased to be able to build upon our global expertise in the cardiovascular therapeutic area with the approval of EDARBI in the U.S. Through the discovery, development and commercialization of new medicines, Takeda is committed to bringing therapies like EDARBI to market. EDARBI is an important new treatment option for patients with hypertension and the health care professionals who treat them.”
Written by Christian Nordqvist