Letairisâ„¢ (ambrisentan), FDA-Approved for Pulmonary Arterial Hypertension

Filed in archive News , Treatment on June 17, 2007

Manufactured by Gilead Sciences, Inc., Letairisâ„¢ (ambrisentan) has recently been approved by the FDA for the treatment of pulmonary arterial hypertension.

Pulmonary arterial hypertension is a rare, life-threatening condition characterized by continuous high blood pressure within the arteries of the lungs.

[In pulmonary arterial hypertension, the small arteries in the lungs become narrowed or blocked, and the heart must work harder to pump the blood through them.

Over time, the overworked heart muscle may become weak and lose its ability to pump enough blood through the lungs.

Symptoms include shortness of breath, fatigue, chest pain, dizzy spells and fainting. About 100,000 people in the United States have pulmonary arterial hypertension.]

According to John Jenkins, M.D., director of FDA's Office of New Drugs:

"Letairis represents a valuable addition to the treatment alternatives for this orphan disease. Letairis is similar to an existing drug, but offers the potential for fewer drug interactions."

Not previously approved in the Unites States, Letairisâ„¢ was granted a priority review by FDA and was granted orphan drug status because it treats a rare disease and meets other criteria.

Letairisâ„¢ will be available in five-milligram and 10-milligram once-daily tablets.

Find more details from the press releases at FDA and Gilead Sciences, Inc.