SK's new anti-epileptic drug files for approval from U.S. watchdog

Lim Chang-won Reporter() | Posted : November 26, 2018, 08:47 | Updated : November 26, 2018, 08:47

[Courtesy of SK Biopharmaceuticals]

SEOUL -- Cenobamate developed by SK Biopharmaceuticals, a pharmaceutical company in South Korea, filed for a new drug application (NDA) in the United States for the commercialization of the novel new anti-epileptic drug that would dramatically decrease median seizure frequencies.

SK Holdings, the holding company of South Korea's third-largest conglomerate, SK Group, said Monday in a regulatory filing that SK Biopharmaceuticals has submitted a new drug application (NDA) for Cenobamate to the Food and Drug Administration (FDA).

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.

Cenobamate has completely eliminated the symptoms of seizure by 11 to 20 percent in clinical trials, SK Biopharmaceuticals officials said earlier. Developers say Cenobamate is reliable, stable and also effective in the adjunctive treatment of different types of partial-onset seizures.

SK Biopharmaceutical 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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