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SK Bio To Go All The Way With Novel Epilepsy Drug

 
• By Jung Won Shin

SK Biopharmaceuticals, the new drug development subsidiary of South Korean conglomerate SK Group, is to seek approval of epilepsy drug YKP3089 without conducting a Phase III efficacy trial and aims to launch the drug globally in 2018, becoming the first domestic pharma to develop, commercialize and market a new product single handedly.

SEOUL - SK Biopharmaceuticals Co. Ltd. has received confirmation that the US FDA will allow it to skip a Phase III efficacy trial for its novel epilepsy drug candidate YKP3089, which recently completed a four-year Phase II program in multiple sites including in the US, Europe and Asia.

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