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FDA needs more data to assess Actelion’s Opsumit in the treatment of inoperable CTEPH

Actelion Pharmaceuticals will need to provide more data to evaluate the use of Opsumit in the treatment of adults with inoperable chronic thromboembolic pulmonary hypertension.

Actelion Pharmaceuticals LTD, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, got a complete response letter from the FDA on its proposed new indication for Opsumit (macitentan).

Actelion’s supplemental New Drug Application (sNDA) for Opsumit for treating CTEPH, to improve pulmonary vascular resistance (PVR) and exercise capacity, is based on investigational data from MERIT-1 (Macitentan for the treatment of inoperable chronic thromboembolic pulmonary hypertension), a Phase II study to assess the efficacy, safety and tolerability of macitentan 10 mg in patients with inoperable CTEPH.

“We will work closely with the FDA to review the information outlined in their letter and gain a full understanding of next steps. We are committed to making a difference in the lives of people living with pulmonary hypertension and CTEPH,” said Martin Fitchet, M.D., Global Head of Actelion Research & Development, Janssen Research & Development, LLC.

Opsumit is a foundational therapy that is an orally active endothelin receptor antagonist (ERA) currently approved in the U.S. for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to reduce the risks of disease progression and hospitalization for PAH.

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