Bayer’s riociguat receives favourable review ahead of FDA committee meeting

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Bayer Healthcare's pulmonary hypertension drug, riociguat, has received a favourable review ahead of the US FDA's Cardiovascular and Renal Drugs Advisory Committee meeting today (6th August).

Briefing documents released ahead of the meeting state that riociguat (which has a proposed trade name of Adempas) is being reviewed as a treatment for patients with chronic thromboembolic pulmonary hypertension (CTEPH) and also for patients with pulmonary arterial hypertension (PAH).

The FDA has already awarded riociguat with priority review. Bayer are seeking approval of the drug for both pulmonary hypertension indications with a starting dose of 1mg thrice-daily titrated up to a maximum dose of 2.5mg. However, in the briefing documents, FDA reviewer Preston Dunnmon wrote that dosing should be modified to start at 0.5mg thrice-daily for PAH up to maximum of 1.5mg thrice daily.

If riociguat is ultimately approved by the FDA, it would be the first drug for CTEPH, but would go up against three other classes of drugs for PAH.