Bayer HealthCare submits hypertension therapy for approval

Bayer HealthCare has announced that its oral investigational drug riociguat has been submitted for approval as a therapy for hypertension in the US and EU.

The drug, which is specified for the treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) is the first in a novel class of compounds called soluble guanylate cyclase stimulators.

It is the first drug ever to demonstrate clinical efficacy in a phase III trial among inoperable CTEPH sufferers and has also proven its potentially beneficial performance among PAH patients in a separate study.

Kemal Malik, member of the Bayer HealthCare executive committee and head of global development, said: "These regulatory submissions … not only represent important progress in our cardiovascular pipeline, but also fuel our hope to bring this much-needed new treatment option for these serious and potentially fatal diseases to patients and doctors."

Last week, the company announced it has initiated and will coordinate a newly founded pan-European consortium, named European Lead Factory, which will focus on enhancing drug discovery efforts.