Johnson & Johnson filed an application with the European Medicines Agency for approval of its esketamine nasal spray Spravato to treat adults with major depressive disorder who have active suicidal ideation with intent.
The nasal spray is already approved in the U.S. and Europe as a medication for adults with treatment-resistant depression.
J&J unit Janssen Pharmaceuticals Inc.'s application is backed by data from two late-stage clinical studies named Aspire I and Aspire II. Results from the studies showed Spravato to be superior in decreasing depressive symptoms versus placebo.
The company filed an application with the U.S. Food and Drug Administration in October 2019 seeking expanded approval for Spravato to treat depression with suicidal intent. The drug won the FDA's breakthrough-therapy designation in August 2019 for this use.