Actelion Wins U.S. FDA Approval for Lung Disorder Therapy

Actelion Ltd. won U.S. approval for the lung drug Opsumit, giving the Swiss company a successor to a best-selling medicine that loses patent protection in late 2015.

The Food and Drug Administration said today it approved Opsumit, also known as macitentan, as a once-daily pill for the treatment of pulmonary arterial hypertension. Similar to other members of its class, the therapy will carry a warning that it shouldn’t be used if pregnant, the FDA said in a statement.

Actelion Chief Executive Officer Jean-Paul Clozel has bet the future of the company he co-founded on Opsumit, including fighting off a hedge fund that sought seats on the board and wanted the company to consider selling itself in 2011. Sales of the drug will reach 1 billion Swiss francs ($1.1 billion) in 2017, according to the average of six analyst estimates compiled by Bloomberg.

The company’s current top seller, Tracleer, had sales of 1.5 billion francs last year, accounting for 87 percent of revenue. The drug has been losing market share to Gilead Sciences Inc.’s Letairis, after the FDA allowed the Foster City, California-based company to remove a reference to the risk of liver damage from the drug’s label in 2011.

Opsumit Availability

Physicians are advised to measure signs of liver damage prior to initiation of Opsumit and repeat during treatment as clinically indicated, Actelion said today in a statement.

Opsumit will be available to U.S. patients next month, the company said.

GlaxoSmithKline Plc sells Letairis outside the U.S. under the brand name Volibris. Tracleer’s U.S. patent expires in November 2015, and in Europe it may face generic competition from the first half of 2017.

Opsumit, Tracleer and Letairis belong to a class of drugs called endothelin receptor antagonists that are designed to treat pulmonary arterial hypertension, an incurable disease in which the arteries that carry blood from the heart to the lungs narrow, making the heart work harder and causing elevated blood pressure. That causes symptoms such as chest pain, dizziness and shortness of breath. The disease affects from 1 in 100,000 people to 1 in 1 million people, according to the American Lung Association.

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