March 17th, 2014
Phase 4 Actelion Study Misses Primary Endpoint
Larry Husten, PHD
Actelion announced today that a phase 4 study with its blockbuster drug bosentan (Tracleer) had failed to meet its primary endpoint. The COMPASS-2 trial was a prospective, randomized, double-blind, placebo-controlled trial evaluating the effect of bosentan on the time to first confirmed event in patients with symptomatic pulmonary arterial hypertension (PAH) already receiving treatment with sildenafil. According to the company, a 17% risk […]
October 18th, 2013
FDA Approves New Pulmonary Hypertension Drug from Actelion
Larry Husten, PHD
The FDA today approved macitentan (Opsumit, Actelion), a new oral endothelin-receptor antagonist that is an enhanced version of the company’s bosentan (Tracleer). The drug is indicated to delay disease progression in patients who have pulmonary arterial hypertension (WHO Group I). Last August the results of the pivotal phase 3 trial, SERAPHIN (Study with an Endothelin Receptor Antagonist in Pulmonary […]
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