Posted by Michael Wonder on 18 Jan 2019
Actelion receives complete response letter from U.S. FDA for Opsumit (macitentan) supplemental new drug application
16 January 2019 - Actelion today announced it has received a complete response letter from the U.S. FDA for its supplemental new drug application for Opsumit (macitentan) in the treatment of adults with inoperable chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) to improve pulmonary vascular resistance and exercise capacity.
The complete response letter indicates additional data are needed to evaluate the use of Opsumit in the treatment of CTEPH.
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.
