The U.S. Food and Drug Administration today (March 4) announced that monthly liver enzyme tests are no longer required for those taking Letairis tablets (ambrisentan), used to treat high blood pressure in the vessels that carry blood to the lungs (pulmonary arterial hypertension, or PAH).
Citing data from clinical trials and postmarket reports, the FDA said that the drug poses only a low risk of liver injury. Information related to potential serious liver injury and the need to monitor for such serious injury is being removed from the drug’s boxed warning.
In patients with PAH, Letairis slows the worsening of symptoms and improves the ability to exercise. Approved in 2007, Letairis is in a class of medications called endothelin receptor antagonists, which stop the action of endothelin, a substance that narrows blood vessels and prevents normal blood flow in those with PAH.
“We have concluded that monthly liver enzyme testing for patients taking Letairis, as previously noted in the boxed warning, is not necessary,” said Mary Ross Southworth, Pharm.D., deputy director for safety in the Division of Cardiovascular and Renal Products at the FDA’s Center for Drug Evaluation and Research. “Health care professionals should still continue to order liver enzyme tests when they consider it clinically indicated.”
Letairis was approved with a Risk Minimization Action Plan (RiskMAP) to manage liver damage and fetal malformation. The RiskMAP called for liver enzyme testing prior to treatment and monthly during treatment for all patients. It also required monthly pregnancy testing for women of childbearing potential because Letairis causes birth defects in animals, like other drugs in this class. The Letairis RiskMAP was converted to a Risk Evaluation and Mitigation Strategy in 2009.
The boxed warning on the risk of serious birth defects and the contraindication for use during pregnancy will remain in the labeling. Letairis will continue to be available only through a restricted distribution program called the Letairis Education and Access Program (LEAP). For women who can become pregnant, monthly pregnancy tests will still be required before Letairis is shipped.
The liver warnings were based on experience with other drugs in Letairis’ drug class, as well as a few observed instances of increased liver enzymes in people treated with Letairis. The FDA’s further evaluation has shown that rates of liver problems in Letairis-treated patients are consistent with rates within the general PAH population. In the controlled clinical trials, the rates of liver problems in Letairis-treated patients are similar to the rates in people receiving an inactive pill (placebo).
For a discussion of the FDA’s rationale and regulatory decisions regarding Letairis, refer to the Drug Safety Communication issued today.
People who take Letairis should not stop taking it without talking to their health care professional. Health care professionals should order and review tests for liver function as necessary based on the patient’s condition and history. Adverse events involving Letairis should be reported to the FDA MedWatch program1.
Letairis is made by Gilead Sciences Inc., Foster City, Calif.
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Sunday, March 6, 2011
FDA modifies boxed warning for pulmonary arterial hypertension drug Letairis
Friday, February 25, 2011
FDA Approves EDARBI (azilsartan medoxomil) for the Treatment of Hypertension
/PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., today announced that the U.S. Food and Drug Administration (FDA) approved EDARBI (azilsartan medoxomil) for the treatment of hypertension, or high blood pressure, in adults. EDARBI is an angiotensin II receptor blocker (ARB) that lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone that constricts blood vessels. When the angiotensin II receptor is blocked, blood vessels stay relaxed and open and blood pressure can be reduced. EDARBI is approved as a once-daily oral therapy for use alone and for use in combination with other antihypertensive medications.
Takeda Global Research & Development Center, Inc. U.S. submitted a new drug application (NDA) for EDARBI in April 2010. The NDA was supported by seven controlled phase 3 clinical trials involving more than 5,900 patients with hypertension. Pivotal phase 3 studies showed EDARBI (80 mg/day) was statistically superior to placebo and the highest approved doses of two commonly prescribed ARBs, olmesartan medoxomil (40 mg/day) and valsartan (320 mg/day), in lowering both clinic and 24-hour mean blood pressure measurements.
"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.," said Shinji Honda, president and CEO, Takeda Pharmaceuticals North America. "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."
The safety and efficacy of EDARBI were studied as a once-daily oral therapy, as well as in combination with chlorthalidone and amlodipine. Results from the phase 3 clinical trials showed EDARBI successfully met the primary endpoint, change in 24-hour mean systolic blood pressure (SBP) as measured by Ambulatory Blood Pressure Monitoring, with statistical significance of lowering blood pressure compared to placebo and head-to-head active comparators. Specifically, results from one study showed EDARBI at doses of 80 mg/day and 40 mg/day lowered 24-hour mean SBP by 14.3 mm Hg and 13.2 mm Hg from baseline, respectively. The blood pressure reductions of EDARBI (80 mg/day) were statistically superior to those of the active comparators valsartan 320 mg/day (-10.0 mm Hg) and olmesartan medoxomil 40 mg/day (-11.7 mm Hg). Similar results were observed in all three comparator studies. The most common adverse reaction in adults was diarrhea (2%).
About 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.
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