Optimal Labeling For Opsumit Allows Actelion To Drop Promotion Of Tracleer
This article was originally published in The Pink Sheet Daily
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.
You may also be interested in...
The latest drug development news and highlights from our US FDA Performance Tracker.
Actlelion is banking on labeling advantages and strategic pricing to propel sales of its new drug for pulmonary arterial hypertension, Opsumit, even after its best-selling PAH drug, Tracleer, goes generic.
Positive opinions for new medicines were relatively scarce in Europe this month, with only Lundbeck's new antidepressant, Brintellix and Actelion's PAH therapy, Opsumit, being recommended for approval.