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Review decision on sNDA for Actelion’s Tracleer awaits finalized REMS

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Actelion must finalize the Risk Evaluation and Mitigation Strategy for Tracleer (bosentan) before FDA will finish reviewing its sNDA for less severe pulmonary arterial hypertension, according to an agency "complete response" letter announced March 2. Actelion submitted a REMS proposal in September 2008, but FDA is now delaying action on the expanded indication until the REMS is finalized and approved by the agency. Tracleer has been marketed since 2001 for patients with moderate to severe PAH with a risk management plan to manage the associated safety concerns of potential for serious liver injury and damage to fetuses. When FDA gained the REMS authority under the FDA Amendments Act last March, it included Tracleer among the marketed drugs with existing risk management plans that needed to turn those plans into REMS

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