The FDA has approved azilsartan medoxomil (Edarbi, Takeda) for the treatment of high blood pressure. The new angiotensin II receptor blocker (ARB) will be available in 80 milligram and 40 mg doses. The recommended dose is 80 mg once daily. The 40 mg dose is used in combination with a diuretic.
The FDA said that in clinical studies azilsartan medoxomil was more effective than valsartan (Diovan) and olmesartan (Benicar) in lowering 24-hour blood pressure.
In a separate development, Takeda yesterday announced that it had submitted an NDA for a fixed-dose combination of azilsartan medoxomil plus chlorthalidone.
Here is the FDA press release:
FDA approves Edarbi to treat high blood pressure
The U.S. Food and Drug Administration today approved Edarbi tablets (azilsartan medoxomil) to treat high blood pressure (hypertension) in adults.
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).
“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.”
Edarbi will be available in 80 milligram and 40 mg doses, with the recommended dose set at 80 mg once daily. The 40 mg dose will be available for patients who are treated with high-dose diuretics taken to reduce salt in the body.
Blood pressure is the force of blood pushing against the walls of the arteries as the heart pumps. If blood pressure rises and stays high over time, it can damage the body in many ways. Nearly 1 in 3 adults in the United States has high blood pressure, which increases the risks of stroke, heart failure, heart attack, kidney failure, and death.
Edarbi is an angiotensin II receptor blocker (ARB) that lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone.
Adverse reactions reported by patients taking Edarbi in clinical trials were similar to those reported by those taking an inactive drug (placebo).
Edarbi has a boxed warning that says the use of the drug should be avoided in pregnant women because use of the drug during the second or third trimester can cause injury and even death in the developing fetus. If a woman becomes pregnant while using the drug, it should be discontinued as soon as possible.
Edarbi is made by Takeda Pharmaceutical North America of Deerfield, Ill.
- National Heart Lung and Blood Institute: What is High Blood Pressure?www.nhlbi.nih.gov/health/dci/Diseases/Hbp/HBP_WhatIs.html
- Approved Drugs: Questions and Answers http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm
Here is the Takeda press release from yesterday:
Takeda Submits New Drug Application in the U.S. for Azilsartan Medoxomil Plus Chlorthalidone, an Investigational Fixed-Dose Combination for the Treatment of Hypertension
Deerfield, Ill., February 23, 2011, and Osaka, Japan, February 24, 2011 – Takeda Pharmaceutical Company Limited (Takeda) announced today that Takeda Global Research & Development Center, Inc. U.S., submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational fixed-dose combination of azilsartan medoxomil plus chlorthalidone (CLD) for the treatment of hypertension, or high blood pressure. Discovered by Takeda, azilsartan medoxomil is an angiotensin II receptor blocker (ARB) that lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone. Chlorthalidone is a long-acting oral thiazide-like diuretic used in the treatment of hypertension. The NDA submission was supported by four phase 3 clinical trials involving more than 4,000 patients with hypertension.
“Millions of patients with hypertension do not have their condition under control,” said Darryl Sleep, M.D., vice president, clinical science, Takeda Global Research & Development Center, Inc. U.S. “We believe this compound, the first in the U.S. to combine an ARB with chlorthalidone, could potentially provide an important new treatment option for patients with hypertension and the health care providers who manage them.”
In a phase 3 clinical trial, azilsartan medoxomil (20 mg/day, 40 mg/day and 80 mg/day), combined in a fixed-dose with CLD (12.5 mg/day and 25 mg/day), was studied versus azilsartan medoxomil and CLD monotherapies. In other studies, the fixed-dose combination of azilsartan medoxomil plus CLD was compared to azilsartan medoxomil coadministered with hydrochlorothiazide (HCTZ), another diuretic, and with a fixed-dose combination of olmesartan medoxomil and HCTZ.
Results from a phase 3 clinical trial of the fixed-dose combination of azilsartan medoxomil plus CLD were previously presented at the American Society of Hypertension, Inc. (ASH), 25th Annual Scientific Meeting and Exposition in New York in May 2010. The 10-week, randomized, double-blind study compared the effect of CLD and HCTZ, both in combination with azilsartan medoxomil, on systolic and diastolic blood pressure (SBP, DBP) by clinic blood pressure measurement and by ambulatory blood pressure monitoring (ABPM) in 609 patients with hypertension.
Hypertension, or high blood pressure, is a chronic medical condition in which blood pressure is elevated at levels of 140 mm Hg or greater systolic or 90 mm Hg or greater diastolic. Hypertension impacts approximately 75 million Americans, or nearly one in three adults. It is estimated that nearly one billion people are affected by hypertension worldwide, and this figure is predicted to increase to 1.5 billion by 2025. Hypertension typically has no symptoms. Adults of all ages and backgrounds can develop hypertension; however, the risk of developing the condition increases with age, with more than half of people over age 60 affected. Hypertension is also costly to the nation’s health care system. The American Heart Association recently estimated that direct and indirect expenses associated with hypertension cost the nation more than $73 billion in 2009.
About Fixed-Dose Combination of Azilsartan Medoxomil Plus Chlorthalidone
Developed by Takeda, azilsartan medoxomil plus chlorthalidone is an investigational fixed-dose combination for the treatment of hypertension, or high blood pressure. The fixed-dose combination of azilsartan medoxomil plus chlorthalidone contains two medications, azilsartan medoxomil, an angiotensin II receptor blocker, and chlorthalidone, a long-acting thiazide-like diuretic used in the treatment of hypertension. The most commonly reported adverse drug reactions occurring in at least two percent of azilsartan medoxomil plus CLD-treated patients at the recommended doses and greater than azilsartan medoxomil or chlorthalidone monotherapies were increased blood creatinine (11%), dizziness (8.2%), blood uric acid (3.8%), blood urea (2.8%), and fatigue (2.5%). Most elevations of creatinine were transient and were generally associated with large blood pressure reductions.
About Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.
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