Takeda ARB blood pressure medication approved by FDA

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Takeda ARB blood pressure medication approved by FDA

Submitted by Mechele R. Dillard on 2011-02-26

Edarbi, made by Takeda Pharmaceutical North America of Deerfield, IL, has been approved by the U.S. Food and Drug Administration for high blood pressure patients.

The U.S. Food and Drug Administration approved azilsartan medoxomil, known commercially as Edarbi, to treat high blood pressure in adults. The clinical research data collected for Edarbi indicated that the tablets were more effective in lowering the 24-hour hypertension level of patients than two other drugs already approved by the FDA, Diovan (valsartan) and Benicar (olmesartan). Edarbi is an angiotensin II receptor blocker (ARB), which lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone.

The damage caused by hypertension can be varied and significant. Blood pressure is the force of one’s blood pushing against the walls of the arteries as the heart pumps blood throughout the body. If blood pressure remains high, it increases the risk of stroke, heart failure, heart attack, kidney failure and death. Almost 1 in 3 adults in the United States today has high blood pressure, the FDA says.

The American Heart Association explains that the top number of a blood pressure reading, the systolic, measures the pressure in arteries when the heart muscle contracts, while the bottom number, the diastolic, measures the pressure when the heart muscle is resting between beats and refilling with blood. A “normal” adult blood pressure is when the systolic is less than 120 and the diastolic is less than 80.

“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.”

Patients will be able to get Edarbi in a 80 milligram or a 40 mg dose. The recommended dose is set at 80 mg once per day. The 40 mg dose will be an option for patients treated with high-dose diuretics taken to reduce salt in the body.

Side effects of Edarbi during clinical trials were minimal, and were comparable to those taking the placebo. But, the drug will have a boxed warning indicating that the drug should not be used by pregnant women during the second or third trimester, as it can cause injury, even death, to a developing fetus. If a woman becomes pregnant while taking Edarbi, she should discontinue use as soon as possible.

http://www.huliq.com/10473/takeda-arb-blood-pressure-medication-approved-fda