The European Medicines Agency (EMA) has recommended against Adempas (riociguat) for patients with symptomatic pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP), according to a recent press release.
EMA’s recommendation follows Bayer Pharmaceuticals‘ announcement in May for the immediate termination of the Phase 2 RISE-IIP clinical trial for the drug after the team observed an increased risk of death or serious adverse events among patients receiving riociguat, compared to patients receiving placebo.
The trial involved 145 PH-IIP patients randomized to riociguat or placebo. At the time of the interim analysis that led to the termination of the study, 21 patients had died, 17 of which from the riociguat group.
PH associated with chronic idiopathic interstitial pneumonias is a high blood pressure in the arteries of the lungs caused by a lung disease called IIP. The disease is characterized by a distinct etiology and patient characteristics, especially because of effects from the two conditions on lung function. There are currently no approved treatment; evidence from studies indicate that survival is poor.
Riociguat (Adempas) belongs to a class of drugs called soluble guanylate cyclase stimulators that help arteries relax in order to increase blood flow and decrease blood pressure.
Adempas is the only drug approved in the United States for use in two types of PH – pulmonary arterial hypertension (PAH) and persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), WHO (World Health Organization) Groups 1 and 4, respectively. Such approvals were based on results from large and controlled clinical trials.
PH-IIP belongs to WHO Group 3.
Adempas has been authorized in the European Union since March 2014 as a therapy to increase the ability of adult patients with PH to carry out physical activities.
EMA will now update Adempas’ product information to add a PH-IIP warning in order to help ensure that the drug is not prescribed and used in that particular patient population. The population for which Adempas is currently authorized is different from those included in the RISE-IIP clinical trial.
More information about the “Efficacy and Safety of Riociguat in Patients With Symptomatic Pulmonary Hypertension (PH) Associated With Idiopathic Interstitial Pneumonias (IIP) (RISE-IIP)” clinical trial can be found at www.clinicaltrials.gov (NCT02138825).