January 31st, 2014
John Ryan offers a primer on three newly approved drugs for pulmonary arterial hypertension.
October 18th, 2013
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 […]
October 9th, 2013
The FDA approved on Tuesday a new drug for pulmonary hypertension. Bayer HealthCare’s riociguat (brand name Adempas) was approved for two indications: the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class the treatment of adults with pulmonary arterial hypertension (PAH) to improve […]
August 7th, 2013
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). Bayer proposed an initial dose of 1 mg three times daily and a maximum dose of 2.5 […]
July 29th, 2013
This week’s topics include riociguat for chronic thromboembolic pulmonary hypertension, renal outcomes associated with invasive vs. conservative management of ACS, statins and musculoskeletal conditions, arthropathies, and injuries, and more.
July 25th, 2013
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 […]
July 25th, 2013
Two multicenter clinical trials published in the New England Journal of Medicine explore the role of a new oral pulmonary vasodilator in pulmonary hypertension.