Bayer HealthCare’s riociguat recommended for US approval

Bayer HealthCare has announced that its oral soluble guanylate cyclase stimulator riociguat has been recommended for US regulatory approval in two forms of pulmonary hypertension.

The US Food and Drug Administration's (FDA's) cardiovascular and renal drugs advisory committee has voted unanimously in support of the drug's use as a therapy for pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.

Its positive decision was based on the encouraging outcomes of the phase III trials Chest-1 and Patent-1, which demonstrated the safety and efficacy of the drug in both of these indications.

Dr Kemal Malik, member of the Bayer HealthCare executive committee and head of global development, said: "Bayer appreciates the scientific discussions by the advisory committee and looks forward to working with the FDA as they finalise their review."

The company has also submitted the drug for regulatory approval in Europe, while results from the Chest-1 and Patent-1 trials were recently published in the New England Journal of Medicine.