Johnson & Johnson's (NYSE:JNJ) Janssen Research & Development, LLC announced that the FDA has granted Breakthrough Therapy Designation (BTD) to esketamine, an experimental antidepressant treatment. 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.
We note that J&J recently got BTD for two other drugs as well. In Jul 2016, the company’s cancer treatment, Darzalex (daratumumab) got the designation for use in combination with standard of care regimens for multiple myeloma patients.
Earlier in Jun 2016, the company and its partner AbbVie Inc. (NYSE:ABBV) got a fourth BTD for Imbruvica. The FDA granted BTD to Imbruvica for the treatment of chronic graft-versus-host-disease (cGVHD) after one or more lines of systemic therapy have failed. Imbruvica was also granted Orphan Drug Designation for the indication.
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).
J&J is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Actelion Ltd. (OTC:ALIOF) and Geron Corporation (NASDAQ:GERN) – both are Zacks Rank #1 (Strong Buy) stocks.
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