Bayer’s pulmonary hypertension drug approved in US

Bayer HealthCare's pulmonary hypertension drug, Adempas, has been approved for the use in the United States by the FDA. The drug was approved via the FDA's priority review program.

Adempas (riociguat) belongs to a class of drugs called soluble guanylate cyclase stimulators that help arteries relax to increase blood flow and decrease blood pressure. The drug has been approved for two types of pulmonary hypertension:

• for patients with chronic thromboembolic pulmonary hypertension (CTEPH) after surgery or patients who cannot undergo surgery, to improve their ability to exercise;

• and also for patients with pulmonary arterial hypertension (PAH) of unknown causes, inherited or associated with connective tissue diseases, to improve their ability to exercise and to delay clinical worsening of their condition.

Pulmonary hypertension is caused by abnormally high blood pressure in the arteries of the lungs.

"Adempas is the first in its drug class approved to treat pulmonary hypertension and the first drug of any class to be shown to be effective for patients with CTEPH."

Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Drug Products in the FDA's Center for Drug Evaluation and Research.