WEDNESDAY, Oct. 23 (HealthDay News) -- Opsumit (macitentan) has been approved by the U.S. Food and Drug Administration to treat adults with pulmonary arterial hypertension, a debilitating disease characterized by high blood pressure in the lung arteries.
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Pulmonary hypertension causes the heart to overwork, which can limit exercise, cause shortness of breath and create the need for a lung transplant. Opsumit relaxes the lung arteries, decreasing blood pressure in the vessels, the FDA said in a news release.
The drug's safety and effectiveness were evaluated in clinical studies involving 742 people. The medication was found effective in "delaying disease progression," the agency said.
Opsumit's label includes a boxed warning that the medication could harm a developing fetus, so the drug should not be taken by pregnant women, the FDA said.
The drug is marketed by Actelion Pharmaceuticals US, based in San Francisco.
-- Scott Roberts
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