Opsumit filed with FDA for chronic thromboembolic pulmonary hypertension.- Actelion Pharma.

Actelion Pharmaceuticals announced the submission of a supplemental New Drug Application (sNDA) to the 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).

The filing is based on data from the MERIT-1 trial, which showed significant improvements in the primary and secondary endpoint of PVR and 6MWD, respectively, compared with background therapy. Opsumit was well tolerated in this patient population and safety was generally consistent with the known safety profile for Opsumit from previous clinical studies. The study results were presented at the American Thoracic Society (ATS) 2017 and European Respiratory Society (ERS) 2017 and published in The Lancet Respiratory Medicine.

A substantial proportion (almost 40%) of CTEPH patients are deemed inoperable and current pharmacological treatment options for these patients are limited to one therapy only. MERIT-1 provides the first randomized controlled trial data involving patients on combination therapy, addressing a key unmet need in CTEPH.