A new South Korean anti-epileptic drug will be available in the US from as early as April.

The US’ Food and Drug Administration has approved SK Biopharmaceuticals’ anti-epileptic drug XCOPRI (Cenobamate), officials said Friday. The product will be available in the second quarter of 2020 after review by the US Drug Enforcement Administration.

The marketing and sales process will be overseen by SK Life Science, the US subsidiary of SK BIopharmaceuticals based in Paramus, New Jersey.

XCOPRI is approved for the treatment of partial-onset seizures in adult patients aged 18 and older. Effect of XCOPRI in children under 18 is not known.

This approval marks the first time a Korean company has independently brought a compound from discovery to US FDA approval.

Cho Jeong-woo, the CEO of SK Biopharmaceuticals and SK Life Science, cited the XCOPRI approval as a “major step toward our goal of becoming a fully integrated global pharmaceutical company that can discover, develop and deliver new treatment options in epilepsy and central nervous system.”

Both SK Biopharmaceuticals and SK Life Science are under the Korean conglomerate SK Group, which Chairman Chey Tae-won has been directing unwavered focus on pharmas and biopharmaceuticals research and development since 1993. In 2002, Chairman Chey laid out the vision to grow the bio units as one of the core pillars of the group from 2030.

While the precise mechanism by which XCOPRI exerts its therapeutic effect is unknown, it is believed to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents.

The FDA approval is based on results from two global, randomized, double-blind, placebo-controlled studies and a large, global, multi-center, open-label safety study.

In the randomized studies, XCOPRI demonstrated significant reductions in seizure frequency compared to placebo at all doses studied. Up to 20 percent of patients achieved zero seizures during the maintenance phase.

The long-term safety of XCOPRI has been evaluated in the ongoing open-label extensions of the randomized studies and the open-label safety study, SK Biopharmaceuticals said.

Additional clinical trials are investigating the efficacy of XCOPRI in other seizure types.

“Approximately 3 million adults live with epilepsy in the US and according to the Centers for Disease Control and Prevention, nearly 60 percent reported having seizures, even if they took an anti-epileptic drug,” said Beth Lewin Dean, Chief Executive Officer of Citizens United for Research in Epilepsy. “There is an urgent need to advance research and introduce new treatment options. The FDA approval of XCOPRI for the treatment of partial-onset seizures is a welcome option for the epilepsy community.”

In Europe, Arvelle Therapeutics has the exclusive license to develop and commercialize XCOPRI, as agreed between the firms in early 2019.

Serious reactions associated with XCOPRI include drug reaction with eosinophilia and systemic symptoms, QT shortening, suicidal behavior and ideation, and neurological adverse reactions. The most common treatment-emergent adverse events associated with XCOPRI include sleepiness, dizziness, fatigue, double vision and headache.

For women, XCOPRI may cause birth control medicine to be less effective. It is not known if the drug can pass into breastmilk or harm an unborn baby.

Any and all medicinal decisions associated with taking XCOPRI must be done under clinician consultation.

SK Biopharmaceuticals and SK Life Science have a pipeline of eight compounds in development for the treatment of CNS disorders including epilepsy, Lennox-Gastaut syndrome and attention-deficit/hyperactivity disorder, among others.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)