Actelion Needs Further Studies on Opsumit Treatment for Inoperable CTEPH, US FDA Says
Actelion Pharmaceuticals has received a complete response letter from the U.S. Food and Drug Administration (FDA) specifying that the company needs to conduct further studies and obtain more data in order to accurately assess the use of Opsumit (macitentan) in the treatment of patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH). The…