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SK Biopharmaceuticals Submits Epilepsy Drug to U.S. FDA for Approval
Seeking to Sell Drugs in U.S. Market on Its Own
SK Biopharmaceuticals Submits Epilepsy Drug to U.S. FDA for Approval
  • By Choi Moon-hee
  • November 27, 2018, 11:47
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SK Biopharmaceuticals has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its self-developed epilepsy drug candidate Cenobamate.

The SK Group is seeking to enter the U.S. drug market, the largest market in the world, with a self-developed new drug.

The group announced on Nov. 26 that its subsidiary SK Biopharmaceuticals has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Cenobamate, an epilepsy drug candidate that it has developed on its own.

This is the first time that a Korean pharmaceutical company has submitted an NDA to the U.S. authority to directly sell its self-developed new drug instead of licensing it out to a global pharmaceutical company or selling the drug through partner companies.

According to market researcher Global Data, this year’s global epilepsy drug market is worth US$6.1 billion (about 6.9 trillion won) and is expected to grow to US$6.9 billion (about 7.8 trillion won) by 2022. If Cenobamate is approved by the FDA, it is likely to be available in the U.S. market by the first half of 2020 at the earliest.

The industry expects that Cenobamate will bring the yearly profit of SK Biopharmaceuticals up to 1 trillion won (US$900 million) once it is on the market. Despite a low probability of success and long-term deficits, the SK Group has focused on new drug development since 1993 to become a comprehensive global pharmaceutical company.