FDA approves new pediatric indication for Tracleer

The U.S. Food and Drug Administration has approved a new indication for the Actelion Pharmaceutical's drug Tracleer (bosentan). The medication may now be used to treat pediatric patients aged three and over who suffer from idiopathic or congenital pulmonary arterial hypertension (PAH). 

Tracleer is the first FDA-approved drug available in the U.S. for treating pediatric patients with PAH. It is expected to improve pulmonary vascular resistance and make it easier for patients to exercise. The FDA's approval covers a new 32mg dosage in the form of a scored tablet, which is dispersed in a teaspoon of water before being administered orally. 

The advantage of the scored tablet is that physicians have the option to prescribe smaller doses according to the weight of the patient. The smaller dosage tablets are set to appear in U.S. pharmacies in the fourth quarter of 2017. It is already available in 62.5mg and 125mg doses.

"We're pleased our portfolio of treatments continues to grow and pediatric PAH patients will now have a FDA-approved treatment option available," commented Gary Palmer MD, MBA, senior vice president of medical at Actelion Pharmaceuticals U.S. 

PAH occurs when there is an excessively high pressure in the blood vessels leading from the heart to the lungs and results in less oxygen in the blood. There are many possible underlying causes, including congenital heart disease, coronary artery disease, high blood pressure and liver disease. Genetics are also thought to play a part in the condition, although it is more common among older patients. 

Treatment of PAH varies according to the patient, but physicians may prescribe medication, such as Letairis (ambrisentan), Opsumit (macitentan), and Tracleer (bocentan). Inhalers such as Ventavis (iloprost tromethamine) and Tyvaso (treprostinil) may also be prescribed.