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. … Click here to read…
FDA Approves New Pulmonary Hypertension Drug From Actelion
October 18, 2013 by Leave a Comment
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). … Click here to read the full post on Forbes. …
New Drug For Pulmonary Hypertension Approved By FDA
October 8, 2013 by Leave a Comment
The FDA today approved a new drug for pulmonary hypertension. Bayer HealthCare’s riociguat (brand name Adempas) was approved for 2 indications: The treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) (WHO* Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class The treatment of adults with pulmonary arterial hypertension…
New Actelion Drug Found Safe And Effective In Pulmonary Arterial Hypertension– But Does It Save Lives?
August 28, 2013 by Leave a Comment
Macitentan, a new drug for pulmonary arterial hypertension (PAH), appears to be safe and effective, but it is unclear whether it offers any significant advantages over currently available drugs. The drug, a dual endothelin-receptor antagonist, is under development from Actelion as an enhanced version of bosentan (Tracleer). The results of a phase 3 trial, SERAPHIN (Study with an Endothelin…
FDA Panel Recommends Approval For Pulmonary Hypertension Drug From Bayer
August 7, 2013 by Leave a Comment
The FDA’s Cardiovascular and Renal Drugs Advisory Committee recommended approval for Bayer’s new pulmonary hypertension drug, riociguat. The committee voted 11-0 in favor of approving the drug for two forms of pulmonary hypertension: pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTPH). Click here to read the full story on Forbes. …
Novel Pulmonary Hypertension Drug From Bayer Shows Modest Promise In Phase 3 Trials
July 24, 2013 by 1 Comment
A new drug appears to have promising– but not game-changing– effects in people with two forms of pulmonary hypertension. Riociguat, a soluble guanylate cyclase stimulator under development by Bayer, is thought to have vasodilating, antiproliferative and antifibrotic effects. Results of two phase 3 placebo-controlled trials were published today in the New England Journal of Medicine. CHEST-1 studied the clinical impact…
Candidate Therapeutic Target For Pulmonary Arterial Hypertension Identified
May 27, 2013 by Leave a Comment
I don’t normally write about pre-clinical research but my friend and CardioExchange colleague John Ryan has been on a tear lately (he even won a Young Investigator award from the AHA last year) with some fascinating and potentially important research. Briefly, and, I hope, not too simply, Ryan’s research may have uncovered a key mechanism underlying the…
Once Again FDA Rejects Oral Treprostinil For Pulmonary Arterial Hypertension
March 25, 2013 by Leave a Comment
For the second time the FDA has issued a complete response letter rejecting the new drug application (NDA) of oral treprostinil for the treatment of pulmonary arterial hypertension (PAH) . The manufacturer of the drug, United Therapeutics, said in a press release that it planned to discuss the decision with the FDA. “We remain confident that…
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