On Tuesday, the FDA approved Johnson & Johnson’s JNJ supplemental New Drug Application for Spravato (esketamine) CIII nasal spray.

The approval makes the treatment the first and only monotherapy for adults living with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants.

An estimated 21 million adults in the U.S. live with the disease. About one-third of adults will not respond to oral antidepressants alone.

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This approval, granted following FDA Priority Review, is supported by results from the randomized, double-blind, multicenter, placebo-controlled study in which Spravato alone showed a rapid and superior improvement in Montgomery-Asberg Depression Rating Scale (MADRS) total score vs. placebo.

In a post-hoc analysis, Spravato demonstrated numerical improvements across all 10 MADRS items at day 28.

At week 4, 7.6% of patients taking placebo and 22.5% of patients taking Spravato achieved remission (MADRS total score ≤ 12).

Spravato is only available through a restricted program called the Spravato Risk Evaluation and Mitigation Strategy Program.

Last month, the U.S. Food and Drug Administration issued a complete response letter (CRL) to Johnson & Johnson's Biologics License Application for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration in patients with non-small cell lung cancer with epidermal growth factor receptor mutations.

The rejection was related to observations as part of a standard pre-approval inspection at a manufacturing facility.

Price Action: JNJ stock is up 0.74% at $148.12 at last check Tuesday.

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