12 November 2019 - Actelion Pharmaceuticals has announced its decision to voluntarily withdraw the European and other health authority filings still under review to extend the indication of Opsumit (macitentan) to include the treatment of adults with inoperable chronic thromboembolic pulmonary hypertension. 

This decision was not driven by any safety concerns. Actelion intends to generate additional data to support future chronic thromboembolic pulmonary hypertension (CTEPH) filings in Europe, U.S. and worldwide.

Feedback from health authorities, including in the U.S. and Europe, and from recent study site inspections indicated that additional clinical data would be required for approval. As a result, Actelion has decided to withdraw the ongoing worldwide submissions based on the Phase 2 study of Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension (MERIT-1). In the U.S., the FDA issued a complete response letter earlier this year and Actelion is working with them to agree on next steps.

Read Actelion press release