According to Janssen, the company’s Spravato esketamine nasal spray has been approved by the EC as an add-on to oral antidepressants for adult patients with major depressive disorder (MDD) “as acute short term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgment constitute a psychiatric emergency.”
The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion regarding approval of Spravato for this indication in December 2020. Spravato has been approved for the treatment of treatment-resistant MDD in the EU since December 2019, and Janssen filed a type II variation application for the expanded indication in January 2020.
Janssen Research & Development Global Therapeutic Area Head, Neuroscience, Bill Martin commented, “At Janssen, we are committed to reducing the devastating burden caused by serious mental illnesses and this further authorization of esketamine nasal spray by the European Commission is a key milestone in our ongoing work towards this goal. Esketamine nasal spray offers adults with MDD who are in need of urgent relief, an effective treatment to reduce their debilitating depressive symptoms. This authorization provides a new and innovative treatment option to this vulnerable population.”
Read the Janssen press release.
