The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion regarding an expanded indication for Janssen’s Spravato esketamine nasal spray on December 10, 2020. The proposed revision would add the use of Spravato “as acute short-term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency.”
Spravato was initially approved by the EU in December 2019 for the treatment of treatment-resistant major depressive disorder, and Janssen filed a type II variation application in January 2020. In the US, the FDA approved Spravato for the treatment of treatment-resistant MDD in March 2019; Janssen submitted an sNDA to expand the indication to include MDD with active suicidal ideation with intent in October 2019; and the FDA approved the expanded indication in August 2020.
Janssen-Cilag European Therapeutic Area Lead for Mood Disorders Allitia DiBernardo commented, “Immediate intervention for individuals living with major depressive disorder who are in a psychiatric emergency is essential. Whilst currently available antidepressants are effective in treating depressive symptomatology, they can often take weeks to achieve their full effects, which limits their utility in acute, emergency treatment.”
Janssen Research & Development Global Therapeutic Area Head, Neuroscience, Bill Martin said, “There is a pressing need to provide individuals with major depressive disorder who are experiencing a psychiatric emergency with treatments that can rapidly reduce their depressive symptoms. If approved by the European Commission, esketamine nasal spray has the potential to offer individuals relief from debilitating depressive symptoms and address a key unmet need within this population.”
Read the Janssen press release.
