Actelion Pharma withdraws filing of Opsumit for CTEPH

Actelion Pharmaceuticals Ltd, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, 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 (CTEPH). This decision was not driven by any safety concerns. Actelion intends to generate additional data to support future 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 II study of Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension (MERIT-1). In the U.S., the Food and Drug Administration (FDA) issued a Complete Response letter earlier this year and Actelion is working with them to agree on next steps.