ARTICLE | Clinical News

Adempas riociguat regulatory update

July 11, 2016 7:00 AM UTC

EMA’s CHMP recommended against the use of Adempas riociguat from Bayer to treat pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP). CHMP said the recommendation follows the early termination of the Phase II RISE-IIP trial due to safety issues. The study’s IDMC observed that patients receiving Adempas were at a “possible increased risk for death and other serious adverse events” compared to placebo (see BioCentury, May 23). The agency concluded that Adempas did not provide “clinically significant benefit” for the indication. ...