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FDA Accepts Actelion's NDA For Macitentan

12/14/2012 2:14 AM ET

Actelion Pharmaceuticals Ltd. (ALIOF.PK, ATLN.L) Friday said its New Drug Application, or NDA, for macitentan has been accepted by The U.S. Food and Drug Administration.

Macitentan is registered under the name Opsumit, and is used for the treatment of patients with pulmonary arterial hypertension.

Pulmonary arterial hypertension is a chronic disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of an affected individual.

In a random, pivotal, long-term Phase III study, Macitentan was found to reduce the risk of morbidity and mortality event over the treatment period versus placebo.

For patients in the 10 mg and 3 mg dose group, risk was reduced by 45 percent and 30 percent, respectively. Meanwhile, nasopharyngitis, headache and anemia were the most common adverse events associated with the use of macitentan.

The review period is expected to last 12 months from the date of NDA submission.

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by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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