The European Medicines Agency has advised that Adempas should not be prescribed to patients with pulmonary hypertension (PH) associated with idiopathic interstitial pneumonia.
The RISE-IIP study, a randomized, double-blind, placebo-controlled, international trial, was designed to evaluate the safety and efficacy profile of riociguat in patients with symptomatic PH associated with IIP, a disease that belongs to WHO Group 3.
Recently, Bayer announced termination of the Phase 2 trial because of severe complications and increased risk of death in patients taking riociguat compared to 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.
Serious adverse events, such as respiratory diseases or lung infections, were also higher among patients assigned to the riociguat group leading to the assessment that the drug did not provide a clinically significant benefit for PH-IIP patients.
EMA will now update the product information to add a contraindication for patients with PH-IIP, and will inform the healthcare professionals of their recommendations to help ensure that Adempas is not given to patients with this condition.