FDA panel unanimously backs Bayer's riociguat

In a pair of 11-0 votes, FDA's Cardiovascular and Renal Drugs Advisory Committee recommended approval of Adempas riociguat from Bayer AG (Xetra:BAYN) to treat pulmonary hypertension (PAH) and to treat chronic thromboembolic pulmonary hypertension (CTEPH). The oral soluble guanylyl cyclase (sGC) stimulator is under FDA Priority Review, with an Oct. 8 PDUFA date.

For both indications, the panel backed approval of doses ranging from 0.5 or 1.5 mg thrice daily titrated up to a maximum dose of 2.5 mg thrice daily. In briefing documents, FDA reviewers had proposed initiating therapy for both indications at 0.5 mg thrice daily and increasing the dose to a maximum of 1.5 mg thrice daily. Bayer is seeking approval of riociguat for both indications with a starting dose of 1 mg thrice daily titrated up to a maximum dose of 2.5 mg thrice daily (see BioCentury Extra, Aug. 2). ...