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SK̿, ڰ Žž ڸFDA
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Է : 2019-11-22 09:24:56
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žళߺ ӻ㰡 α , K-̿
۸޵ ڣ

SK 100% ȸ SK̿ ž (XCOPRI, ٸƮ) κ ġ ̱ FDA 㰡 ޾Ҵ. ž žĺ ߱ ӻ , Ǹ 㰡 û(NDA, New Drug Application) FDA ̹ ѹα ʴ.


SK̿ ̱ SK̾𽺰 ð ǸŸ þ, 2020 2б⿡ ̱ ø ǥ ϰ ִ.

2001 ӻ 㰡 FDA ž Ǹ 㰡 ȹϿ. ĺ ռ ȭչ 2,000 ̻, ̱ FDA žǸ㰡 û ۼ ڷḸ 230 Ѵ. 迡 ڷ FDA ž ʴ ⿡, ѹα ܰ ø ϰ ִ.

ߺ 㰡, ̱ ѱ SK̿ ̹ SK̿ ߽Ű(CNS, Central Nervous System) о ȯ ž ߱, ȭ ۷ι ŵ쳪 ʼ ̶͡, SK̿ R&D Ұ .

̱ 漾(CDC) ֽ 迡 , 2 ų Ӱ ް , ȯ 60% ġ ص ӵǰ ִ.

̹ 㰡 1-3 ġ ӿ κ ʴ ȯڵ 2 ߸Ͱ ӻ Ը ٱ ¶ ӻ ̷. ̱ ǽõƴ. 迡 뷮 ǹϰ 󵵸 Ÿ.

6ְ Ⱓ ̾ 6ְ ๰ Ⱓ ù ° ӻ(Study 013)  ִ 200mg ȯڵ(n=113) ߾Ӱ 56% , (n=108) 22% Ͱ ǹ Ÿ.

6ְ Ⱓ ̾ 12ְ Ⱓ ̷ ° ӻ(Study 017) 100mg(n=108), 200mg(n=109), 400mg(n=111) ȯڵ ߾Ӱ 36%, 55%, 55% , 24% (n=106) ǹ .

Ӹ ƴ϶ ӻ 迡 ๰ ġ Ⱓ ǹ ȯڵ ۼҽǡ . ๰ Ⱓ ߿ ߻ ʴ ۼҽǡ ȯ ϻ ưٴ ǹ, ų ִ ߿ ҷ ž ÿ ߿ ǥ ޾Ƶ鿩 ִ.

ù ° ӻ м ϸ ๰ ġ Ⱓ 9% ۼҽ ̴ ݸ, 28% ȯڵ ۼҽ . ° ӻ(Study 017) Ⱓ 100mg, 200mg, 400mg ȯڵ鿡 4%, 11%, 21% ۼҽ ޼, 1% 񱳵Ǵ Ÿ.

ӻ ࿡ ʶǾ ۽ コ Ű& Ĺ Ű ۽ ճ(Jefferson Comprehensive Epilepsy Center) ̻ Ű Ŭ ޸(Michael Sperling) ڻ ǻ κ ӵǴ ȯڵ鿡 ȿ ġ ְ ̶͡, ȯڵ鿡 󵵰 ǹ ְ Ͽ, Ϻ ȯڵ鿡 ҽ Ÿ ſ ̴. ߴ.


ζ
, SK̿ ܿ FDA ޾ 7 ̱ 忡 Ǹŵǰ ִ ֽž (и: ָ) FDA ž(ڰ ) 2 ϰ ִ.  
޵ (yjun89@mdtoday.co.kr)
ũ 彺! ũ ڿܼ Ѵٰ?



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