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.

The majority of panelists recommended approving the drug with a 2.5mg limit, saying they wanted as many options as possible and that decisions on dosing should be left to physicians. FDA reviewers recommended the drug be approved at lower doses, arguing that a starting dose of 0.5mg and maximum of 1.5mg three times a day would provide the same benefit as the higher dose with a reduced risk of side effects, particularly hypotension, or low blood pressure.