Actelion Receives a Nod From FDA for Opsumit to Treat Hypertension

A new drug, Opsumit, got a nod from the U.S. Food and Drug Administration to treat adults with pulmonary arterial hypertension (PAH).

Actelion won the FDA approval for Opsumit (macitentan), an oral endothelin-receptor to treat PAH, which is a chronic, progressive and debilitating disease. PAH can lead to the death or demand for lung transplantation.  

The drug belongs to the class of drugs called endothelin receptor blockers, which are known to delay the progression of disease in those who have PAH by relaxing the pulmonary arteries and lowering the blood pressure in the lungs. Opsumit is the enhanced version of the drug bosentan (Tracleer).

PAH is high blood pressure in the arteries that connect heart to lungs. It causes dizziness, fainting, leg swelling and shortness of breath. Due to the high blood pressure, the right side of the heart works harder than normal, leading to limitation in exercise ability and shortness of breath.

To test the safety and effectiveness of the drug, a clinical trial was conducted on 742 participants who were randomly given either Opsumit or placebo for about two years. They noticed that Opsumit successfully delayed the progression of disease, a finding that included drop in exercise ability, worsening symptoms of PAH of need for more PAH medication.

Opsumit like other drugs carries a warning label that cautions pregnant women against the use of drug as it is known to harm the developing fetus. Common side-effects of the drug include common cold-like symptoms, sore throat, headache, flu, urinary tract infection and anaemia.

Female patients can take this only though Opsumit Risk Evaluation and Mitigation Strategy (REMS) Program.