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FDA approves Opsumit for pulmonary arterial hypertension

Drug includes boxed warning, REMS program

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Actelion Pharmaceuticals for treating pulmonary arterial hypertension.

The agency announced the approval of Opsumit (macitentan) for adults with PAH, a chronic, progressive and debilitating disease caused by high blood pressure in the arteries that connect the heart to the lungs that can lead to death or the need for lung transplantation.

The FDA said the drug would carry a boxed warning, the highest warning possible, alerting patients and healthcare providers that Opsumit should not be used in pregnant women because it can harm a developing fetus. Women can only receive the drug through a risk evaluation and mitigation strategy program.

 

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