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Home Industry News Actelion’s Tracleer product receives supplemental FDA approval

Actelion’s Tracleer product receives supplemental FDA approval

11th August 2009

Actelion has had its supplemental new drug application for Tracleer (bosetan) approved by the Food and Drug Administration (FDA), it has emerged.

Tracleer is a treatment for patients with mildly symptomatic WHO Functional Class II (FC II) pulmonary arterial hypertension (PAH).

Additionally, the FDA has also approved the risk evaluation and mitigation strategy for Tracleer.

Actelion’s chief executive Jean-Paul Clozel, said: “Physicians […] who treat PAH patients now have access to Tracleer as an approved therapy for patients not only in advanced, but also in the early stages of this rapidly progressing and life-threatening disease.”

He added that the results of the EARLY study conducted around the drug show that Tracleer noticeably reduces the risk of advancement in those with early stage PAH.

Last month, Actelion announced that the drug had been approved by the European Union and said it was “very proud” of its progression so far.

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