New Drug Approved For Rare High Blood Pressure Called Pulmonary Arterial Hypertension – FDA Says There are Side Effects

New Drug Approved For Rare High Blood Pressure Called Pulmonary Arterial Hypertension – FDA Says There are Side Effects

PA chest radiograph

(Best Syndication) The U.S. Food and Drug Administration (FDA) approved Letairis (ambrisentan) for the treatment a rare, life-threatening condition characterized by continuous high blood pressure within the arteries of the lungs. With pulmonary arterial hypertension (PAH) the small arteries in the lungs become narrowed or blocked, and the heart must work harder to pump the blood through them.

"Letairis represents a valuable addition to the treatment alternatives for this orphan (rare) disease," said John Jenkins, M.D., director of FDA's Office of New Drugs. "Letairis is similar to an existing drug, but offers the potential for fewer drug interactions." The drug was fast-tracked through the FDA because the needs of these patients were not being met by other available drugs.

The agency sets a target date of six months after the date of receipt to complete all aspects of a review and to take action on these priority drug applications. The drug was proven safe and effective by two international clinical trials involving 393 patients.

The FDA says that Letairis “significantly improved physical activity capacity compared with a placebo, as shown by a six-minute walk, a standard test. Letairis also delayed the worsening of the pulmonary hypertension.”

There may be some side effects including swelling of legs and ankles, nasal congestion, sinusitis, and getting red in the face (flushing). Letairis should not be taken by women who are pregnant or may become pregnant because the drug may cause birth defects.

Since the drug is intended for a rare disease, the sponsor will qualify for a tax credit and marketing incentives. Letairis is manufactured by Gilead Sciences, Inc., Foster City, Calif. Gilead acquired the U.S. rights to ambrisentan when it acquired Myogen, Inc. in 2006. GlaxoSmithKline holds rights to ambrisentan outside of the United States.

Patients must have monthly blood tests to check for potential liver injury. Letairis will be available in five-milligram and 10-milligram once-daily tablets.

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By Jeffrey Workman
Best Syndication News Health Writer



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