The FDA has approved Janssen Pharmaceutical’s sNDA for the expanded use of Spravato esketamine CIII nasal spray for the treatment of major depressive disorder with acute suicidal ideation or behavior, the company said. Spravato was initially approved by the FDA in March 2019 for the treatment of treatment-resistant depression, and Janssen announced the submission of the sNDA in October of that year.
In January 2020, the company submitted a Type II variation application to the EMA seeking to expand the use of Spravato for the treatment of major depressive disorder in patients who have active suicidal ideation with intent. The initial European approval of Spravato for treatment resistant major depressive disorder came in December 2019.
Janssen Research & Development Global Therapeutic Area Head, Neuroscience, Bill Martin added, “People living with major depression need more options to meet their most critical needs, and we’re proud to help redefine how we treat ongoing and acutely worsening depressive symptoms. Spravato can now help patients with challenging to treat depression find significant and swift relief from debilitating depressive symptoms, offering those living with this serious mental health condition the possibility of a better future.”
Read the Janssen press release.
