Posted by Michael Wonder on 26 Nov 2018
SK Biopharmaceuticals submits epilepsy drug candidate for approval to US FDA
26 November 2018 - 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 FDA 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.
