FDA reviewers back Bayer's riociguat with modified dosing
FDA reviewers recommended approval of Adempas riociguat from Bayer AG (Xetra:BAYN) to treat pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) with a modified dosing regimen. The recommendation came in soluble guanylyl cyclase (sGC) stimulator, which is under Priority Review in the U.S., with an Oct. 8 PDUFA date.
The reviewers said riociguat is effective for both indications but because the compound causes dose-related decreases in blood pressure that can be "profound," the reviewers recommended approval of a modified dosing regimen. 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. The reviewers 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. For CETPH, the reviewers said patients with high enough systolic blood pressure who do not experience an adequate response can be titrated to a maximum dose of 2.5 mg thrice daily. ...