Janssen R&D LLC
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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.
Advisory committee overwhelmingly endorses approval for patients with treatment-resistant depression but says proposed Risk Evaluation and Mitigation Strategy needs refinement, including clarifying the types of facilities where the drug will be administered.
Janssen’s Esketamine: US FDA Panel To Weigh Efficacy, REMS Restrictions For Treatment-Resistant Depression
FDA proposes requiring that healthcare facilities monitor patients for sedation and dissociative effects for two hours after self-administration; reliance on a randomized withdrawal trial as one of two adequate, well-controlled studies to support approval would be a first in the depression setting.
The Pink Sheet's pick of eight major events that captured major regulatory developments in China’s dynamic, highly fluid biopharma scene in 2018.
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