New anti-epileptic drug from SK's biotech wing to seek FDA approval

Lim Chang-won Reporter() | Posted : November 22, 2018, 09:58 | Updated : November 22, 2018, 09:58

[Courtesy of SK Biopharmaceuticals]

SEOUL -- Cenobamate developed by SK Biopharmaceuticals, a pharmaceutical company in South Korea, is ready to file for a new drug application (NDA) in the United States for its commercialization as clinical trials showed the novel new anti-epileptic drug dramatically decreased median seizure frequencies.

NDA is the vehicle through which drug sponsors formally propose that the U.S. Food and Drug Administration approve a new pharmaceutical for sale and marketing. If approved, Cenobamate, which is in third-stage clinical trial, can compete with a widely used anti-epileptic drug from UCB, a global biopharmaceutical company.

"We were encouraged to completely eliminate the symptoms of seizure by 11 to 20 percent in clinical trials," an SK Biopharmaceuticals official said. Developers say Cenobamate is reliable, stable and also effective in the adjunctive treatment of different types of partial-onset seizures.

SK Biopharmaceuticals, a unit of South Korea's SK group, specializes in the development of drugs for the treatment of central nervous system disorders. The company has set up an independent system of producing and marketing Cenobamate in the global market.

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