The European Medicines Agency (EMA) has recommended that riociguat (Adempas, Bayer) should not be used in those with symptomatic pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP) after review of a safety signal, according to an EMA statement.
The recommendation from the EMA's Committee for Medicinal Products for Human Use follows the early termination of a clinical trial in patients with PH-IIP. The EMA's Pharmacovigilance Risk Assessment Committee initially reviewed the study data and sent the recommendation to the Committee for Medicinal Products for Human Use for its endorsement.
PH-IIP is high blood pressure in the arteries of the lungs caused by idiopathic interstitial pneumonia. Riociguat is not authorized for use in patients with PH-IIP, and a phase 2 clinical trial (RISE-IIP) examining the effect of the drug in the patient population was underway. The trial included 145 patients with PH-IIP who received either riociguat or placebo. The study's primary endpoint was change in the 6-minute walking distance test after treatment for 26 weeks.
Preliminary data showed a higher number of deaths (17 in the riociguat group and four in the placebo group) and serious events, including breathing problems and lung infections, in patients who took riociguat compared with those in the placebo group. Further, there appeared to be no clinically significant benefit for those who took the drug. Riociguat was discontinued in the study patients, and researchers are monitoring those patients closely.
The company will update its product information to add a contraindication for this disorder to help ensure riociguat is not used in patients with PH-IIP. Riociguat is currently authorized for a different patient population than that included in the RISE-IIP study. The drug's benefits continue to outweigh its risks in patients for whom it is currently authorized, according to the EMA statement.
The European Union authorized Adempas March 27, 2014. Riociguat increases the ability to perform physical activities in adults with chronic thromboembolic pulmonary hypertension, idiopathic pulmonary arterial hypertension, heritable pulmonary arterial hypertension, and pulmonary arterial hypertension caused by connective tissue disease.
The EMA instructs prescribers to discontinue riociguat in patients with PH-IIP and to carefully monitor those patients. The EMA will send a letter with the recommendations to healthcare professionals.
The EMA expects the company to take actions according to its recommendations.
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Cite this: Riociguat (Adempas) Not for Patients With PH-IIP - Medscape - Jun 28, 2016.