Posted by Michael Wonder on 01 May 2018
Actelion submits supplemental new drug application to US FDA seeking approval of Opsumit (macitentan) for the treatment of chronic thromboembolic pulmonary hypertension
30 April 2018 - Filing supported by data from MERIT-1 trial evaluating Opsumit in adults with inoperable CTEPH which showed significant improvements in pulmonary vascular resistance and six-minute walk distance compared with ongoing background therapy.
Actelion today announced the submission of a supplemental new drug application to the U.S. FDA seeking to expand the indication of Opsumit (macitentan) to include the treatment of adults with inoperable chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) to improve exercise capacity and pulmonary vascular resistance (PVR).
Opsumit is an orally active endothelin receptor antagonist that is currently approved in the U.S. for the treatment of PAH (WHO Group I) to delay disease progression and hospitalisation.
