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SK Biopharmaceutical is eyeing a share of the 4 trillion won US antiepileptic drug market with its cenobamate tablet Xcopri, which treats partial-onset seizures in adults.
The drug, approved by the US Food and Drug Administration (FDA) on November 21 last year, provides an extra needed treatment option for people with seizures.
Xcopri is the first Korean novel drug, researched and developed entirely and independently by a Korean pharma firm, notes SK Biopharmaceutical CEO Cho.
It is a product of Cho's 15-year research and development drive.
According to the US FDA, the safety and efficacy of XCOPRI were established in two studies that enrolled 655 adults, which were randomized, double-blind, and placebo-controlled.
The FDA granted Xcopri's approval to SK Life Science Inc., the US arm of SK Biopharmaceutical.
Thus, SK Life Science will undertake the US distribution of Xcopri.
