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…
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…
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