FDA approves Bayer's Adempas; firm accelerates drug candidates

The US Food and Drug Administration late yesterday (October 8) approved Adempas (riociguat), developed by German drug major Bayer (BAYN: DE), to treat adults with two forms of pulmonary hypertension.

Riociguat, which has been granted orphan drug status in the USA, is already approved in Canada (The Pharma Letter September 26) and is under review at the European Medicines Agency. The drug will join a pulmonary arterial hypertension (PAH) market expected to grow to a value of $3.57 billion by 2015, according to GlobalData. The current market is dominated by Tracleer (bosentan) – due to lose patent protection in 2015 - from Switzerland’s Actelion. Riociguat could generate $498 million in sales by 2017, according to the average of six analysts’ estimates compiled by Bloomberg.

Adempas belongs to a class of drugs called soluble guanylate cyclase stimulators that help arteries relax to increase blood flow and decrease blood pressure. It is intended for patients with chronic thromboembolic pulmonary hypertension (CTEPH) after surgery or patients who cannot undergo surgery, to improve their ability to exercise. Adempas is also indicated for patients with pulmonary arterial hypertension of unknown causes, inherited or associated with connective tissue diseases, to improve their ability to exercise and to delay clinical worsening of their condition.