J&J’s Esketamine: A Model “Breakthrough” Program For US FDA
J&J’s treatment-resistant depression drug esketamine had an easy time at an FDA advisory committee despite raising some tough regulatory questions. If you are looking for a showcase of how “Breakthrough” drug development collaboration can help a new therapy get to patients faster, this might be it.
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Restrictive risk management plan for antidepressant nasal spray requires patients be monitored for two hours after dosing and enroll in a patient registry; Janssen has agreed to conduct a monotherapy efficacy trial as a postmarketing commitment.
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.