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FDA approves Bayer's riociguat

October 9, 2013 12:31 AM UTC

FDA approved Adempas riociguat from Bayer AG (Xetra:BAYN) to treat pulmonary arterial hypertension (PAH) and inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) after surgery in pulmonary hypertension patients. According to the drug's label, the starting dose is 1 mg thrice daily titrated up to 2.5 mg thrice daily, the dosing regimen for which Bayer had been seeking approval.

In August, an FDA advisory committee unanimously backed approval of riociguat for both indications at the company's proposed titration doses. FDA reviewers had proposed a modified dosing regimen with a starting dose of 0.5 mg thrice daily titrated up to 1.5 mg thrice daily. Riociguat's label does recommend a starting dose of 0.5 mg thrice daily in patients who may not tolerate the drug's "hypotensive effect" (see BioCentury, Aug. 12). ...