Optimal Labeling For Opsumit Allows Actelion To Drop Promotion Of Tracleer

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.