Janssen Pharmaceutical announced that the company has submitted a type II variation application for Spravato esketamine nasal spray to the EMA seeking to expand the use of Spravato for the treatment of major depressive disorder (MDD) in patients who have active suicidal ideation with intent. Spravato was approved in Europe in December 2019 for the treatment of treatment-resistant MDD.
In the US, Spravato was initially approved for the treatment of treatment-resistant MDD in March 2019, and Janssen submitted an sNDA to expand the indication to include MDD with active suicidal ideation with intent in October 2019.
According to Janssen, the new submission is supported by data from the Phase 3 ASPIRE I & II studies of Spravato in addition to standard of care for the treatment of MDD in adult patients with active suicidal ideation and intent. The company had announced in September 2019 that both of those studies met their primary endpoints.
Janssen Research & Development Global Head, Neuroscience Therapeutic Area, Husseini K. Manji said, “Janssen is committed to reducing the devastating burden caused by serious mental health disorders. There is a need to provide treatments that can rapidly reduce depressive symptoms of individuals living with MDD who are in need of urgent relief. We therefore look forward to working with the EMA to provide a new targeted treatment that could potentially deliver meaningful results for these patients.”
Read the Janssen press release.
