18 Aug 2016
FDA has granted Johnson & Johnson’s esketamine Breakthrough Therapy Designation (BTD)
FDA has granted Johnson & Johnson’s esketamine, an experimental antidepressant treatment Breakthrough Therapy Designation (BTD). The designation was granted for major depressive disorder with imminent risk for suicide.
This is the second indication for which esketamine got BTD in the U.S. Esketamine had previously got this designation in Nov 2013 for treatment-resistant depression. Esketamine is currently in phase III development for treatment-resistant depression.
According to information provided by the Centers for Disease Control and Prevention, there are more than 41,000 suicides each year in the U.S. with many resulting from untreated or poorly treated major depression.
BTD helps fasten the development and review of drugs which are being evaluated for the treatment of serious or life-threatening conditions and where preliminary clinical evidence indicates that the drug may be substantially better than existing treatments on clinically significant endpoint(s).