The European Medicines Agency (EMA) recently recommended that Adempas (riociguat) should not be used by patients with symptomatic pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP).
The recommendation was issued after the early termination of the Phase 2 clinical trial, “Efficacy and Safety of Riociguat in Patients With Symptomatic Pulmonary Hypertension (PH) Associated With Idiopathic Interstitial Pneumonias (IIP) (RISE-IIP),” which was investigating the effects of the drug candidate for PH-IIP.
The trial’s preliminary results showed deaths and considerable adverse effects among patients being treated with Adempas (riociguat) when compared to the placebo (control) group. Side effects included breathing problems and lung infections. No significant benefits were observed.
Patients included in the study (NCT02138825) ceased treatment immediately and are currently being carefully monitored. PH-IIP is described as high blood pressure in the arteries of the lungs caused by a lung disease called idiopathic interstitial pneumonia.
The terminated clinical trial included 145 PH-IIP patients with hopes of improved health after 26 weeks of treatment. But, at the time of interim assessment 21 deaths had occurred – 17 who took Adempas and four patients on placebo.
Product information for the drug will be updated to state its contraindication for PH-IIP patients.
Adempas therapy has proven positive benefits for patients with the following conditions:
- Chronic thromboembolic pulmonary hypertension (CTEPH, where the blood vessels of the lungs are blocked or narrowed with blood clots).
- Pulmonary arterial hypertension (PAH, characterized by thickening of blood vessel walls in the lungs). For PAH, efficacy has been shown in patients with idiopathic (of unknown cause) or heritable PAH or PAH (causality attributed to connective tissue disease).
Healthcare professionals will receive a letter with the EMA recommendation concerning findings for Adempas (riociguat) therapy.