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Optimal Labeling For Opsumit Allows Actelion To Drop Promotion Of Tracleer

 
• By Sten Stovall

With a ‘clean’ label that differentiates macitentan from current standard of care, Actelion’s got what it wanted from FDA: a newly approved next-generation drug with a long patent life that can expand its presence in the pulmonary arterial hypertension market, and, importantly, protect its core franchise from upcoming generic competition.

Actelion Pharmaceuticals Ltd.’s newly approved drug for pulmonary arterial hypertension, Opsumit (macitentan), is differentiated enough for the company to drop promotion in the U.S. of its major product, Tracleer, and commit its resources to the new follow-on.

On a conference call with analysts Oct. 21, Chief Operating Officer Otto Schwarz said that the company’s U.S. commercial efforts “are moving completely to Opsumit,” but he emphasized that it...

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