An investigational epilepsy drug developed by a Korean company has been recognized by the U.S. Federal Drug Administration (FDA) and will be approved only with a safety test, bypassing a phase 3 clinical trial to evaluate efficacy.

SK Biopharmaceuticals Co., SK Group’s pharmaceutical unit, said on Monday it completed discussion with the FDA over new drug approval conditions after successfully ending its phase 2 study of YKP3089.

The achievement reflects SK Group Chairman Chey Tae-won’s persistency on the drug development, market watchers say. The group launched a drug development program in 1993 and continued investments led by the chairman despite business uncertainty. SK Biopharmaceuticals conducted phase 2a and 2b studies of the epilepsy drug in America, Europe and Asia for four years. Results showed superior efficacy and safety to existing therapies, leading to confirmation from the FDA that additional studies to evaluate efficacy can be skipped.

Data from a phase 2b study showed a 55 percent reduction in seizure frequency in patients with intractable epilepsy who were resistant to existing drugs, delivering two times higher efficacy than existing drugs, a company official said.

The proportion of patients with complete recovery from seizure after treatment is the highest compared to drugs available in the market. SK plans to file an NDA with the FDA for commercial marketing of the drug next year after a phase 3 study to evaluate safety. Marketing for global markets seems to be possible from 2018.

According to Datamonitor Healthcare’s data, the global epilepsy therapeutics market is estimated to grow at 6 percent a year from $4.9 billion in 2014 to $6.1 billion in 2018. SK plans to seek global marketing on its own, the first such attempt by a Korean drug developer. The move is aligned to its goal to become a global healthcare company. SK Biopharmaceuticals received approval of clinical trials of 15 investigational drugs from the FDA, the largest portfolio of drugs on track to clinical trials among Korean pharmaceutical companies. Of the candidate drugs, SKL-N05, an investigational sleep disorder drug, is under a phase 3 study and PLUMIAZ, an acute seizure drug, reached the NDA submission stage.

By Chung Wook

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