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Janssen’s Esketamine Gets US FDA Panel Endorsement, But With Pricing, Access And Diversion Concerns

Executive Summary

Committee overwhelmingly supports approval for treatment-resistant depression but warns that pricing and combination therapy indication could hinder patient access. Esketamine’s risks of sedation and dissociative effects, and its abuse potential, will necessitate a strict risk management strategy.

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Datamonitor projects the newly US FDA-approved esketamine product for treatment-resistant depression will reach sales of almost $2bn in the US, Japan and five major European markets.

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