The European Commission has approved Janssen Pharmaceutical’s Spravato esketamine nasal spray for the treatment of treatment-resistant major depressive disorder, the company said. The EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion regarding the MAA for Spravato in October 2019.
The FDA approved Spravato for the same indication in March 2019. In October 2019, Janssen announced that it had submitted a supplemental NDA to expand the use of Spravato to the treatment of major depressive disorder in patients with active suicidal ideation with intent.
Janssen Research & Development Global Head, Neuroscience Therapeutic Area, Husseini K. Manji commented, “The EC approval of esketamine nasal spray provides a new way to manage treatment-resistant major depressive disorder with a novel mechanism of action. Janssen is committed to reducing the devastating burden caused by serious mental illnesses, and we are proud to be introducing a new and innovative treatment option, which will help to address a significant unmet need.”
Read the Janssen Pharmaceuticals press release.
