FDA approves Opsumit (Actelion) for PAH

The FDA has on 18 October 2013, approved Opsumit (macitentan) from Actelion, a new drug to treat adults with Pulmonary Arterial Hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or the need for lung transplantation.

Opsumit belongs to a class of drugs called endothelin receptor blockers, which act to relax the pulmonary arteries, decreasing blood pressure in the lungs. Opsumit�s safety and effectiveness were established in a long-term clinical trial where 742 participants were randomly assigned to take Opsumit or placebo. The average treatment duration was about two years. In the study, Opsumit was effective in delaying disease progression, a finding that included a decline in exercise ability, worsening symptoms of PAH or need for additional PAH medication.