New breakthrough designation for Janssen's depression candidate esketamine
The US Food and Drug Administration (FDA) has granted esketamine, an investigational antidepressant medication, Breakthrough Therapy Designation for the treatment of major depressive disorder with imminent risk for suicide.
It is the second time that the drug, which is being studied by Janssen, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), has been granted this status by the regulator, having received the designation for treatment-resistant depression in November 2013.
The program in treatment-resistant depression is currently in Phase III, with six ongoing clinical trials.
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