Janssen Pharmaceutical has submitted an MAA to the EMA for its esketamine nasal spray for the treatment of treatment-resistant depression in adults with major depressive disorder, the company said. Janssen submitted an NDA for the nasal spray to the FDA in September 2018.
Janssen Global Head Research & Development Mathai Mammen said, “Major depressive disorder affects approximately 40 million people across Europe, and is the leading cause of disability worldwide. Of these people, about one-third do not respond to currently available treatments. Janssen is committed to improving the outcomes for patients with treatment-resistant depression, and we look forward to working with the EMA to provide a new targeted treatment option for these patients.”
The MAA is supported by data from 5 Phase 3 studies, including 3 short-term studies, a withdrawal study, and a long-term safety study. In May 2018, Janssen announced results from 2 of the studies.
Read the Janssen Pharmaceuticals press release.
