FDA panel votes Tracleer approvable

FDA's Cardiovascular and Renal Drugs Advisory Committee today unanimously voted that Actelion's (SWX:ATLN) and partner Genentech's (DNA) Tracleer is approvable to treat pulmonary arterial hypertension (PAH). In a short meeting, the panel quickly agreed that Tracleer bosentan oral endothelin receptor A and B antagonist showed efficacy in the reduction of symptoms of PAH and at increasing walking distance. Debate centered on the identification of a dosing plan to maximize patient benefit while minimizing risk of hepatotoxicity. Panel members questioned whether a lower dose regimen could retain clinical benefit. In addition, the panel recommended establishment of a patient registry to ensure effective post-marketing reporting of adverse events. ATLN was up CHF1 to CHF51 in Swiss trading on Friday prior to the announcement, and DNA, which was trading at the time of the announcement, was up $0.15 to $42.06. ...