Azetukalner’s epilepsy NDA is backed by 1,500 patient-years. Do psychiatric adverse events change the regulatory equation?
Xenon Pharmaceuticals has submitted azetukalner for FDA approval in focal seizures after strong Phase 3 efficacy and more than 1,500 patient-years of epilepsy exposure. On the same day, the company paused new enrollment in psychiatry studies after neuropsychiatric adverse events emerged, creating a difficult question over how regulators and investors should interpret safety signals that