FDA Advisory Panel Recommends Bayer’s Hypertension Drug, Rejects Dosing Cap

An FDA advisory committee Tuesday unanimously recommended approval of Bayer’s pulmonary arterial hypertension (PAH) drug Adempas, and rejected suggestions by agency reviewers that the drug only be allowed up to 1.5mg doses three times daily. The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 11-0 in favor of both proposed indications — PAH and chronic thromboembolic pulmonary hypertension (CTEPH).
Drug Industry Daily