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Dailypharm

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ѱ ž ַƼ ľó 㰡
ΰ 2019-09-05 16:16:21
ѱ ž ַƼ ľó 㰡
ΰ 2019-09-05 16:16:21

240mg 1ȸ 1ȸ 120mg ֻ

FDA ߵ ȹ, ౺ پ

[ϸ=ΰ ] ѱ ž 'ַƼ(īָ, )' ǰǾǰó 㰡 ޾Ҵ.

ѱ(ǥ ˺ ) 5 ľóκ ַƼ120mg/ml ʵֿ ַƼ120mg/ml ʵø 2 ޾Ҵٰ .

ַƼ 뷮 뷮 240mg(120mg 2ȸ ֻ) 1ȸ ϰ, 1ȸ 120mg ֻϴ ̴.

ڰַƼ ù CGRP . ߿ ֿ ϴ Į Ÿ̵(Calcitonin gene-related peptide, CGRP) ڿ ü ϴ ΰȭ Ŭ ü ๰̴.

̹ 㰡 1773 ȭ ȯڸ 6 2 ӻ ȯ 1113 3 ӻ ƴ.

ȭȯ( ϼ 4-14) 1773 EVOLVE-13 EVOLVE-2 4. ȯ( ϼ 15, ϼ 8 ̻) 1113 REGAIN̴.

" ߻ ϼ ϰ ҽ ġ 1 ȿ " ߴ.

ѱ EVOLVE-2 ӻ ڰַƼ (226, 4.3) 6 ߻ ϼ ౺(450, 2.3) 2 ߴ. Ⱓ ߻ 50% ڰַƼ 59%(౺ 36%), 75% ̻ ȯڴ 34%(౺ 18%), 100% ȯڴ 12%(౺ 6%) Ÿ.

ȯڰ REGAIN ӻ 3 ߻ ϼ ô. ڰַƼ (19.4) (19.6) ڰַƼ 273(4.8) 538(2.7) ߻ ϼ ϰ ҽ״ ̴. ߻ ϼ 50% ȯڴ 28%(౺ 15%).

ڰַƼ FDAκ 2018 9 ο ġ ޾Ҵ. 2019 6 ο ߵ ġ ߰ ȹߴ. ռ ߵ ġ ġ (Breakthrough Therapy Designation) ִ.
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ֽż ݴ
ٺ Ϲݾ ǸŰ (2024 03)
뱸- ౹ 37
ǰ ְ
̰źĸ(100) 35,000 29,000 6,000 31,083
ѽŻ÷(10) 3,500 2,500 1,000 3,144
޾(100) 24,000 22,000 2,000 22,800
Ʒγΰ(100) 30,000 27,000 3,000 28,586
īɾ(10g) 8,000 5,500 2,500 6,773
Ľõ򿬰(5g) 5,500 4,000 1,500 5,104
Ź(4) 5,000 3,500 1,500 4,350
λ絹÷(100) 37,000 30,000 7,000 33,889
ڶ(20) 6,500 6,500 0 6,500
(10) 6,000 4,500 1,500 5,238
Ժ(10) 4,000 3,300 700 3,699
ڱ׸(20) 5,000 4,000 1,000 4,597
ť(10) 3,500 2,500 1,000 3,073
Ȱť(1) 1,200 1,000 200 1,199
Ǯɾ(3.3ml) 27,000 25,000 2,000 26,143
޵𿬰(10g) 7,000 6,000 1,000 6,463
öŸ(34) 13,000 11,000 2,000 12,009
뽺ī(20g) 22,000 18,000 4,000 20,462
ġ(1) 1,000 1,000 0 1,000
ӽ÷(21) 10,000 7,000 3,000 9,121
ͺ(10) 3,500 2,500 1,000 3,126
ݿ(1ڽ) 3,000 2,800 200 2,984
׶÷糪ƮŸ(6) 8,000 7,000 1,000 7,952
߽Ÿ(120) 60,000 55,000 5,000 57,842
Źĸ(10ĸ) 3,000 2,000 1,000 2,992
Ÿ̾(120) 60,000 50,000 10,000 55,000
տ(60ĸ) 30,000 25,000 5,000 27,844
Ÿ̷ER(6) 3,000 2,500 500 2,912
ٿ(30g) 12,000 9,800 2,200 11,515
(120) 25,000 22,000 3,000 24,429
Ʒ(6) 4,000 3,000 1,000 3,498
ǽõĸ(270ĸ) 120,000 105,000 15,000 116,250
B(120) 70,000 60,000 10,000 64,111
׳(10) 3,000 2,500 500 2,810
6̺(10) 3,500 2,100 1,400 3,027
(60) 220,000 200,000 20,000 212,000
Ⱦ 12,000 10,000 2,000 10,967
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ּ: ı 128 SK V1 GL ƮνƼ A 401ȣ
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