Oct 18 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.