VIENNA (dpa-AFX) - The U.S. FDA has approved Opsumit (macitentan), a new drug to treat adults with pulmonary arterial hypertension or PAH, to delay disease progression. The effectiveness of the orally available endothelin receptor antagonist was established in a long-term study in PAH patients with predominantly WHO Functional Class II-III symptoms treated for an average of 2 years. Opsumit is marketed by San Francisco-based Actelion Pharmaceuticals US, Inc. The company noted the FDA approval of the drug was based in part on data from the landmark phase III SERAPHIN study.
Pulmonary arterial hypertension, is high blood pressure, that occurs in the arteries that connect the heart to the lungs. It causes the right side of the heart to work harder than normal, which can lead to limitations on exercise ability and shortness of breath. Opsumit belongs to a class of drugs called endothelin receptor blockers, which act to relax the pulmonary arteries, decreasing blood pressure in the lungs.
Jean-Paul Clozel, CEO of Actelion, said: 'The approval of Opsumit is providing the PAH community with a unique treatment option, the only oral PAH medicine that has proven to delay disease progression. Over the last 14 years, Actelion has worked tirelessly to first discover and then develop Opsumit in the largest, longest and first-ever outcome study in PAH.'
FDA stated that the drug should not be used in pregnant women because it can harm the developing fetus. Female patients can receive the drug only through the Opsumit Risk Evaluation and Mitigation Strategy Program.
Actelion Ltd (ALIOF.PK)) is a biopharmaceutical company with its corporate headquarters in Allschwil/Basel, Switzerland. Actelion shares are traded on the SIX Swiss Exchange as part of the Swiss blue-chip index SMI.
In the United States, Actelion expects Opsumit to become available to patients in November.
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