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J&J Submits NDA to the FDA for Depression Drug in Adults

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Johnson & Johnson (JNJ - Free Report) announced that it has submitted a New Drug Application (NDA) to the FDA for esketamine nasal spray seeking approval for treatment-resistant depression in adults.

The NDA was based on five pivotal phase III studies of esketamine nasal spray — three short-term studies, one withdrawal maintenance of effect study, and one long-term safety study — in patients with treatment-resistant depression.

Per the company, esketamine restores connections between brain cells in patients suffering from treatment-resistant depression using glutamate receptor modulation.

We remind investors that the FDA had already granted Breakthrough Therapy Designations to esketamine nasal spray for treatment-resistant depression and for major depressive disorder (MDD) with imminent risk for suicide. Janssen is currently conducting phase III studies in patients with MDD.

The company also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for esketamine seeking approval for treatment-resistant depression later in 2018.

J&J’s stock declined 3.4% this year so far against growth of 3.9% recorded by the industry.

 

Approximately 300 million patients suffer from major depressive disorder globally. Among these, about one-third do not respond to currently available treatments. Hence, a potential approval will provide a good market opportunity.

The market for MDD is huge. Minerva Neurosciences, Inc. (NERV - Free Report) is also developing candidates for the treatment of MDD. The company is developing seltorexant (also known as MIN-202 or JNJ-42847922) in collaboration with Janssen Pharmaceutica (part of Johnson & Johnson) and MIN-117 for the treatment of MDD.

Meanwhile, J&J has a robust pipeline. The company expects to launch or file for approval of more than 10 new blockbuster products by 2021. The company is targeting more than 50 line extensions of existing and new drugs as well.

Zacks Rank & Key Picks

J&J carries a Zacks Rank #3 (Hold).

Some better-ranked large-cap drug stocks are Eli Lilly & Company (LLY - Free Report) and Bristol-Myers Squibb Company (BMY - Free Report) . While Bristol-Myers sports a Zacks Rank #1 (Strong Buy), Lilly has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Bristol-Myers’ earnings estimates increased to $3.62 from $3.43 for 2018  and to $3.83 from $3.65 for 2019 over the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 6.39%.

Lilly’s earnings estimates increased to $5.47 from $5.15 for 2018 and to $5.69 from $5.47 for 2019 over the last 60 days. The company delivered a positive earnings surprise in each of the trailing four quarters, with an average beat of 10.15%.

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