SK Biopharmaceuticals, the new drug development unit of South Korea’s telecom-to-energy conglomerate SK Group, said Monday that it had submitted a new epilepsy drug candidate to the US Food and Drug Administration seeking marketing approval.
SK Biopharm said it had submitted a new drug application for Cenobamate, which is intended to treat epilepsy, a neurological disorder characterized by recurrent seizures. If approved on schedule, the drug is expected to hit the market within the first half of 2020, the firm said.
It marks the first time that a Korean company has directly sought FDA approval for a new drug without first entering a licensing agreement with a global pharmaceutical company, according to SK Biopharm.
The Korean drugmaker is seeking FDA approval for Cenobamate after a long-term clinical study involving 2,400 epilepsy patients in North America, Europe, Asia and Central and South America.
“Though multiple epilepsy drugs exist, more than half the epilepsy patients worldwide continue to suffer from seizures, raising demand for novel treatments,” SK Biopharm said in a statement, citing Global Data’s projections that the global epilepsy treatment market will reach $6.9 billion in 2022, an increase of 12 percent over 2018.
In addition to Cenobamate, SK Biopharm is currently awaiting the FDA’s decision on a treatment candidate for narcolepsy, Solriamfetol. The firm submitted a new drug application for Solriamfetol to the FDA in December and the drug was accepted for review in March this year.
SK Biopharm, together with SK Biotek, a manufacturer of active pharmaceutical ingredients, are at the center of SK Group’s efforts to nurture the pharmaceutical business as a future growth engine and its stated mission to establish itself as a “fully integrated pharma company.”
By Sohn Ji-young (firstname.lastname@example.org)