Actelion pulls supplemental indication applications for Opsumit

13 November 2019

Actelion Pharmaceuticals has decided 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, now one of the Janssen Pharmaceutical companies of Johnson & Johnson (NYSE: JNJ), intends to generate additional data to support future CTEPH filings in Europe, USA and worldwide.

Opsumit is already on the market for the treatment of pulmonary arterial hypertension and generated sales of $347 million in the third quarter of the current year.

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