Shots:

• The approval is based on two global studies (Study 013 and Study 017) assessing XCOPRI vs PBO and demonstrated significant reductions in seizure frequency vs PBO at all doses studied
• Study 013 results: XCOPRI (200 mg/day) (56% vs 22%)- zero seizures (28% vs 9%); Study 017: XCOPRI (100 mg/day). During maintenance phase of 013- 017 reduction in median seizures @ 100/200/400 mg/day (36%- 55%- 55% vs 24 %); (4%- 11%- 21% vs 1%)
• XCOPRI (cenobamate tablets) is an anti-epileptic drug targeted for partial-onset seizures in adults with expected availability in the US in Q2’2020. Additionally- in 2019 SK biopharma signs an exclusive license agreement with Arvelle Therapeutics to develop and commercialize in EU

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