Bayer HealthCare hypertension drug to receive priority FDA review

Bayer HealthCare's new riociguat therapy for hypertension has had its strong potential underlined by a review ruling from a US regulatory body.

The Food and Drug Administration (FDA) has granted priority review status to the oral investigational drug, recognising its promise of offering major advances in care for a condition where no adequate therapy currently exists.

Riociguat is being assessed as a potential treatment for two distinct forms of the ailment – inoperable chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension – by regulators in the US and EU.

Data from two pivotal phase III trials showed that it is the first drug therapy to offer robust efficacy against both of these disease variants.

Dr Kemal Malik, member of the Bayer HealthCare executive committee and head of global development, said: "We hope that we will soon be in a position to provide patients and doctors with a new treatment option."

The drug is the first in a novel class of compounds called soluble guanylate cyclase stimulators and was submitted for approval in the US and Europe in February 2013.