New Option For Uncontrolled Epilepsy On Horizon As US Accepts Cenobamate NDA

New potentially effective therapy for drug-resistant epilepsy, seen as the most pressing unmet need in this market, is on the horizon as FDA begins approval review of SK’s cenobamate, also marking a first for the Korean pharma industry.

Epilepsy
US FDA begins NDA review of SK's Cenobamate • Source: Shutterstock

The US FDA has formally accepted SK Life Science Inc.’s new drug application (NDA) for cenobamate, the Korean firm's investigational antiepileptic for the treatment of partial-onset seizures in adults, paving the way for the company's goal of bringing to market an effective therapy for drug-resistant epilepsy, seen as the most pressing unmet medical need in this segment.

Cenobamate (YKP3089), discovered and developed by SK Biopharmaceuticals Co. Ltd

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