FDA Approves Bosentan for Pediatric Pulmonary Arterial Hypertension
Bosentan for pediatric PAH is expected to launch at the end of 2017.
The US Food and Drug Administration (FDA) has approved a new strength of bosentan (Tracleer®; Actelion) tablet for oral suspension for use in children aged ≥3 years with idiopathic or congenital pulmonary arterial hypertension (PAH), to improve pulmonary vascular resistance, which is expected to result in an improvement in exercise ability.
The new 32 mg tablet for oral suspension marks the first FDA-approved drug for pediatric PAH. Prior to this, bosentan was approved for the treatment of PAH (WHO Group I) in adult patients to improve exercise ability and decrease clinical worsening.
The 32 mg scored tablet can be dispersed in one teaspoon of water prior to oral administration. The lower dosage and scored design enables physicians to vary the prescribed dose according to patient weight.
Bosentan is an orally active endothelin receptor antagonist (ERA) at endothelin receptor types ETA and ETB. Endothelin-1 (ET1) is a neurohormone that is elevated in plasma and lung tissue of patients with PAH, suggesting a pathogenic role for ET-1 in this disease.
Bosentan is also available as 62.5 mg and 125 mg tablets for adult use. The 32 mg tablets for oral suspension will be available in 56-count cartons or 14-count blister strips. The product is anticipated to launch by the 4th quarter of 2017.
Actelion receives FDA approval of Tracleer (bosentan) for use in pediatric patients with pulmonary arterial hypertension [news release]. South San Francisco, CA: Johnson & Johnson; September 6, 2017.