Actelion Receives Complete Response Letter from FDA for OPSUMIT

Actelion Pharmaceuticals has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for OPSUMIT® (macitentan) in the treatment of adults with inoperable chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) to improve pulmonary vascular resistance (PVR) and exercise capacity. The complete response letter indicates additional data are needed to evaluate the use of OPSUMIT in the treatment of 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.

The proposed new indication 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 (WHO Group 4). Data from MERIT-1 has been published in The Lancet Respiratory Medicine.

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. For all female patients, OPSUMIT is available only through a restricted program called the OPSUMIT Risk Evaluation and Mitigation Strategy (REMS).

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