SK Bio files NDA for epilepsy drug

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SK Bio files NDA for epilepsy drug

SK Biopharmaceuticals, a subsidiary of SK Holdings, said on Monday that it has submitted an application to the U.S. Food and Drug Administration to begin sales of its new epilepsy drug.

The approval is set to pave the way for SK to begin selling Cenobamate in the United States, the largest biopharmaceutical market in the world, by the first half of 2020 at the earliest.

This is the first time that any Korean pharmaceutical company has submitted a new drug application (NDA) to the U.S. authority for a new drug product that it has developed on its own.

Cenobamate has been designed to treat intractable central nerve system diseases like epilepsy on the back of top-notch technology and expertise, SK Biopharmaceuticals said. Should the new drug be approved for commercialization, SK Biopharmaceuticals could grow into a comprehensive pharmaceutical company that is responsible for not only research and development, but also production and sales, the company noted.

“We will closely cooperate with the process of the FDA reviewing our NDA,” said Cho Jeong-woo, CEO of SK Biopharmaceuticals. “We will continue developing intractable disease treatments that work on the central nervous system and cancer.”

Having conducted clinical tests on 2,400 patients in America, Europe and Asia, SK Biopharmaceuticals has submitted the NDA through SK Life Science, its U.S. operation.

Several medical institutions have conducted placebo-controlled phase two clinical trial tests over two rounds as well as phase three large-scale long-term safety tests on epilepsy patients who suffered partial onset seizures.

Epilepsy, a neurological disorder, has seen a flurry of treatments thus far. More than half of patients still suffer seizures, raising the demand for a new treatment.

According to market researcher Global Data, the global epilepsy treatment market is set to grow by an accumulated 12 percent from this year to $6.9 billion by 2022.

SK began developing drugs in 1993. After SK Holdings became the holding company of SK Group, the country’s third-largest conglomerate, in 2007, the pharmaceutical arm was placed directly under the holding company to receive full support for research and development.

Last year SK Biopharmaceuticals filed an NDA for Solriamfetol, a treatment to improve wakefulness jointly developed by Jazz Pharmaceuticals. The company is still waiting for a ruling.

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