Bayer's PAH/CTEPH drug gets unanimous backing from FDA advisory panel

In what was largely expected following this week’s briefing papers from US Food and Drug Administration staffers (The Pharma Letter August 5), Germany’s largest drugmaker, Bayer (BAYN: DE), said late yesterday that the FDA’s Cardiovascular and Renal Drugs Advisory Committee recommended approval for investigational compound riociguat, proposed trade name Adempas, in two forms of pulmonary hypertension.

The Committee voted 11 to 0 that riociguat should be approved for the treatment of pulmonary arterial hypertension (PAH]) of WHO Group 1. The Committee also voted unanimously that riociguat should be approved for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) of WHO Group 4. It has been forecast by analysts that Adempas could generate sales of nearly half a billion dollars by 2017.