United withdraws Remodulin file ahead of FDA meeting

United Therapeutics has withdrawn its marketing application forRemodulin (UT-15), a drug for pulmonary arterial hypertension, in the USA, just days before a US Food and Drug Administration advisory committee is due to review the drug's dossier.

United submitted its New Drug Application for Remodulin in PAH to the FDA last year and, in accordance with US legislation, the agency was required to reach a decision on the application no later than July 16. As the panel meeting fell outside the mandated review period, the company has been required to withdraw the NDA, but said it "will resubmit it upon a favorable advisory committee recommendation by...August 10."

United's main competitor in the PAH program, Switzerland's Actelion, will have its drug candidate Tracleer (bosentan) reviewed by the panel on August 10, in what has been described as a "make-or-break" event for the company by analysts at Swiss broker Sarasin. Actelion has delayed the publication of its first-half financial results due to the drain on resources caused by the upcoming meeting.