Actelion Ltd has won U.S. approval for its drug Opsumit, a successor to its pulmonary arterial hypertension drug Tracleer, which loses patent protection in 2015.
Pulmonary arterial hypertension, or PAH, is characterized by high blood pressure in the arteries connecting the heart to the lungs, which causes the right side of the heart to work harder than normal and causes shortness of breath.
Opsumit belongs to a class of drugs known as endothelin receptor antagonists, which relax the pulmonary arteries and decrease that pressure.
The drug, like others in its class, carries a boxed warning, the most serious possible, that it should not be used in pregnant women because it can harm the fetus.
The FDA based its approval on a clinical trial that showed Opsumit was effective in slowing progression of the disease.
The Swiss company reported sales of Tracleer in 2012 of 1.5 billion francs, making it the company's biggest selling product. Actelion is banking on Opsumit to make up for an expected decline in Tracleer sales once it loses market exclusivity.
Opsumit will compete with, among others, Gilead Sciences Inc.'s Letairis, which is sold outside the United States by GlaxoSmithKline Plc under the brand name Volibris.
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