2 May 2018 - - Allschwil, Switzerland-based Actelion Pharmaceuticals Ltd, one of the Janssen Pharmaceutical Companies of Johnson and Johnson, has submitted a supplemental new drug application (NDA) to the US Food and Drug Administration seeking to expand the indication of Opsumit (macitentan) to include the treatment of adults with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) to improve exercise capacity and pulmonary vascular resistance, the company said.
Opsumit is an orally active endothelin receptor antagonist (oral ERA) that is currently approved in the US for the treatment of PAH to delay disease progression and hospitalization.
The filing is based on data from the MERIT-1 trial, a Phase II prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group study to assess the efficacy, safety and tolerability of 10 mg macitentan in patients with inoperable CTEPH, which showed significant improvements in the primary and secondary endpoint of pulmonary vascular resistance (PVR) and six-minute walk distance (6MWD) compared with ongoing background therapy.
Opsumit was well tolerated in this patient population and safety was generally consistent with the known safety profile for Opsumit from previous clinical studies.
Actelion became part of the Janssen Pharmaceutical Companies of Johnson and Johnson in June 2017, expanding and strengthening Janssen's portfolio with differentiated in-market medicines and promising late-stage compounds. Janssen has added PAH as a therapeutic area of focus to maintain a leadership position Actelion has built in this important disease area.
The Janssen Pharmaceutical Companies of Johnson and Johnson (NYSE: JNJ) work to find new and better ways to prevent, intercept, treat, and cure disease. The pharmaceutical segment offers various products in the areas of immunology, infectious diseases and vaccines, neuroscience, oncology, and cardiovascular and metabolic diseases.