30 August 2018 - Filing supported by data from MERIT-1, evaluating macitentan in adults with inoperable CTEPH which showed significant improvements in pulmonary vascular resistance and six-minute walk distance, compared with placebo (with or without background therapy).

Actelion Pharmaceuticals today announced the submission of a Type II Variation to the EMA seeking to expand the indication of Opsumit (macitentan) to include the treatment of adults with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) of WHO Functional Class II to III to improve exercise capacity.

If approved, Opsumit would be the first therapy in its class available in the EU for the treatment of inoperable CTEPH.

Read Actelion press release