Following the recommendation from the European Medicines Agency, the European Commission approved Johnson & Johnson's esketamine nasal spray Spravato for treatment-resistant major depressive disorder.
Patients with treatment-resistant depression have shown a lack of response to at least two different antidepressant treatments.
The commission approved Spravato, or esketamine, in combination with a selective serotonin reuptake inhibitor, or serotonin and norepinephrine reuptake inhibitor, to treat adults with the disorder.
The approval granted to J&J's Janssen Pharmaceuticals Inc. was based on data from five late-stage studies that evaluated over 1,600 patients in three short-term studies and one long-term study and one randomized withdrawal and maintenance of effect study.
Results from the studies showed about 70% of patients experiencing a 50% or more reduction in symptoms with benefits coming as early as day two of the treatment. About 50% of the patients receiving the Spravato combination had no signs of the disease at week 4. Continued treatment with the combination showed a reduced in the risk of the disease coming back.
Spravato was approved by the U.S. Food and Drug Administration in March for treatment-resistant depression. Earlier in October, the company filed another application with the regulator for expanded approval of the drug to treat adults with major depressive disorder who have active suicidal ideation with intent.
Major depressive disorder affects about 40 million people of all ages in Europe.