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J&J Seeks Label Expansion for Spravato Nasal Spray in EU

Zacks Equity Research

Johnson & Johnson’s JNJ submitted a type II variation application to the European Medicines Agency (EMA), seeking label expansion of Spravato (esketamine) nasal spray in patients with major depressive disorder (MDD) who have current suicidal ideation with intent in Europe.

A supplemental new drug application seeking a similar label expansion was filed in the United States in October this year. The application was based on data from two phase III studies, ASPIRE I & II, which demonstrated that Spravato combined with comprehensive standard of care led to rapid reduction of depressive symptoms in adult MDD patients who have active suicidal ideation with intent.

J&J’s shares have performed in line with the large-cap pharma industry in the past year. The stock has returned 14.9% in the said timeframe.



Spravato was approved by the FDA in March last year for treatment-resistant depression (TRD) in adults. With the approval, Spravato, which was thought to work differently than currently approved therapies, was the first new medicine in 30 years to treat depression, a difficult-to-treat mental disease. J&J claimed that while most antidepressants take a couple of weeks or months to show effects, Spravato works in hours

To avoid misuse and abuse of the drug, Spravato was approved with a boxed warning on its label regarding a Risk Evaluation and Mitigation Strategy (REMS) and the risk of suicidal thoughts and behaviors in pediatric patients and young adults. Spravato was approved in Europe in December last year.

On the third-quarter conference call, J&J had said that the drug was off to a strong start and patient demand was strong.

J&J’s another new drug approved last year was Balversa (erdafitinib) for metastatic urothelial cancer. J&J believes that both Spravato and Balversa have the potential for more than $1 billion of peak revenues.

The depression market is quite large and has many players including biggies like Allergan AGN with products like Vraylar and Viibryd and Eli Lilly LLY with Cymbalta and Zyprexa.

J&J currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Another top-ranked stock in the space is Bristol-Myers BMY with a Zacks Rank #2. Bristol-Myers’ earnings estimates have increased 9% for 2020 over the past 60 days. The stock has risen 35.6% in the past year.

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