Rival firms face FDA panel for PAH drugs

US-based United Therapeutics and Switzerland-based ActelionPharmaceuticals were due to appear before a US Food and Drug Administration advisory committee on August 10 in an attempt to be the first to market their products, Remodulin (UT-15) and Tracleer (bosentan), respectively, as a treatment for pulmonary arterial hypertension, a disease for which the only therapy currently available is GlaxoSmithKline's Flolan (epoprostenol).

Both drugs are administered via different methods; Remodulin is delivered under the skin through a pump whilst Actelion is administered twice-daily in a tablet formulation.

United filed for European Union approval of Remodulin earlier this year (Marketletter February 12), but had to withdraw its marketing application to the FDA due to the panel meeting falling outside the mandated review period. However, the firm has said that it will submit the application again upon a favorable advisory committee recommendation. Actelion has also filed for EU authorization (Marketletter March 5), and if the US regulatory authorities grant approval, the drug will be marketed by Genentech.