Actelion Receives FDA Approval of TRACLEER

Actelion Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has approved a new 32 mg tablet for oral suspension for TRACLEER (bosentan) for use in pediatric patients aged three years and older with idiopathic or congenital pulmonary arterial hypertension (PAH), to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability. With this approval, TRACLEER becomes the first FDA-approved medicine for pediatric PAH patients in the United States. PAH is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of an affected person.

TRACLEER is an orally active endothelin receptor antagonist (ERA) for the treatment of patients with PAH. This approval covers a new 32 mg dosage of TRACLEER, which features a scored tablet. The tablet can be dispersed in a teaspoon of water before oral administration. The lower dosage and score lines on the tablets are designed to allow physicians to vary the prescribed dose by the weight of the patient.

"Actelion has focused on the needs of the PAH community since TRACLEER, our first treatment for PAH, was approved in 2001," said Gary Palmer, M.D., MBA, senior vice president, Medical, Actelion Pharmaceuticals. "We're pleased our portfolio of treatments continues to grow and pediatric PAH patients will now have an FDA-approved treatment option available."

Actelion expects to make the 32 mg dosage option of TRACLEER available by the fourth quarter of 2017. The existing 62.5 and 125 mg dosages for adult use will remain available.

TRACLEER is an oral ERA, which is a medication that helps PAH patients by blocking the effects of the extra endothelin their bodies produce. Endothelin is a naturally occurring chemical in the body and is involved in blood flow.

However, patients with PAH have levels of endothelin that are higher than normal. Researchers have found that too much endothelin can cause blood vessels to tighten. It is more difficult for blood to flow through tightened blood vessels, and this can affect how well the heart works.

PAH is high blood pressure in the arteries of the lungs. It's a serious condition that can make it difficult for blood to flow through the lungs, which can force an affected individual's heart to work harder.

PAH is a chronic and progressive disease. This means that over time, PAH will get worse. PAH is a rare disease and not all causes are known. While PAH can affect people at any age, the average patient is diagnosed in their late 40s. And although anyone can develop PAH, it affects almost four times as many women as men.

PAH involves a change in the levels of several natural chemicals in the blood. Over time, this can cause the arteries in the lungs to become thick and stiff, which can make it difficult for blood to flow. As a result, the heart must work harder to pump blood from the right side of the heart through the arteries of the lungs.