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

14 Feb 2019

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.

Depression or nervous breakdown disorder of mental health psychotherapy diagnosis for therapy depression.

A US FDA advisory committee endorsed Janssen R&D LLC’s esketamine as a potentially game-changing therapy for treatment-resistant depression but also identified some commercial challenges for the sponsor.

Members of the Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee on Feb

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