24.03.29 () 23:11

Dailypharm

X
ȯ ġ , ϱ?
ϸ 2013-04-10 12:24:53
ȯ ġ , ϱ?
ϸ 2013-04-10 12:24:53
ѿ ȸ(ȸ)



ݷ׷ 츮 ʿ , LDLݷ׷Ѱ ̸ ݷ׷ . ǥ鿡 ִ LDL ü Ͽ  ظ 鼭 ŵǰų Ϻδ HDLݷ׷Ѱ ݷ׷ѷ ȯȴ.  ü ų Ͽ LDL ݷ׷ ŵ ϸ ߿ ݷ׷ 󵵷 ϰ ȴ. 幰 ߿ LDL ݷ׷ ִ ȯڵ ִ( ݷ׷, familial hypercholesterolemia). ȯ 鸸 Ѹ ÷ ߰ߵǴ ȯν ȯڵ 30 帶 ϰ Ǵ Ȥ ȯ̴.

׷ ֱ ȯڵ ִٴ ҽ Դ. ̱ FDA 12 Juxtapid (Aegerion), 1 Kynamro (Sanofi) ̵ ȯڵ ݷ׷ ž Ͽ ̴. VLDL (LDL ü) ݷ׷ ٿ LDLݷ׷ ߴ ۿ Ѵ. ź ž ΰ ȯڵ ñ ڽ Ʈ ְ Ǿ. ̿ ȯ ġ žళ 忡 ο ȭΰ ǰ ִ.

ȯ Ǵ ݾ ٸ. ̱ ȯڼ 20 , Ϻ 5 , ѱ 2 ȯ . ̿ α ȯڼ 5 Ϸ ߻ ȯ ϰ ִ. ̷ ü α ѱ Ϻ 0.04%, 0.05%, ̱ 0.075% شѴ. ̷ ȯ ȯڼ ſ õ ̾ϰ ̵ ȯ ſ ̴. ̷ ġ ߵǾ ϰ ̵ ȯ ٷ ǻ ۿ .

ΰ ǰ ϴ 뷫 7000 Ѵ. ߿ 6000 ȯ ϴµ ̵ κ ܼ Ͼ. ̷ پ ȯ ׳ ġ ִ ȯ ܿ 200 ġ ݱ ġ 400 Ұϴ. ν ȯ ֱ ȰȭǾ ؾ ȯ ٴ ȴ.

"̱ ȯ ġ 900"

ȯ ġ ũ⸦ ѹ . ȯ ΰ ִ ȯڴ ̱ 뷫 3000 ߻ϰ ִ. ̱ α 10% ڴ. α 6~8% ȯ ȯڷ Ѵ. ȯ 1δ 1 ప 뷫 3000 ( ̺ ׼ ξ .) ü ȯڵ ϰ Ǵ ġ ̱ 1Ⱓ 900 ̸. ̴ ۷ι 忡 ǸŵǴ ü Ǿǰ Ը 900 Ը̴. ׷ ֱٿ õǴ ȯ ġ Ư εٰ, ̱Ӹ ƴ϶ ۷ι Ը Ȯϸ ȯ ġ  ũⰡ . ó Ǿ ִ ȯ ġ Ը ü Ǿǰ Ը 10% 90 ϸ ɼ ϴٰ .

Ŵ ȯ ġ ߿ ʾҾ. ȯڱ ۾Ƽ Ÿ ߱Ⱑ ̶ . ݱ ĸ 索, , , , ȯ ȯ ַϴ ȯ ġ ߼ұԸ Ǿ.  ϱ ƴ ̾ ̴. ׷ ä п ̵ ȯ ġ ġ ʰ Ӽ 忡 Ͽ ū ŵξ. (Genentech), 긮̵ (Celgene), 缾Ƽ(Genentech), Ʈ(Genentech), (Amgen), ż (Teva), ƮŬ (Actelion), ̵ (Millennium) ̴.

׷ ̷ 帧 ȭ Ͼ ִ. 4~5ʹ ĸ鵵 ȯ ġ ָϱ Ͽ. Ϲ ġ 忡 ȭǰ ְ, 鿩 ߴ ž࿡ ׸ ν â⿡ ް ִ Ͷ ο ȯ ġ ã ϴ ̴. ̷ 帧 ݿϵ Pfizer, GSK, Norvatis ȯ ġ ߿ پ Sanofi ȯ ġ ߿ ȸ翴 Genzyme縦 μϱ⿡ ̸. ̷ ٸ ĸ鿡Ե ı޵ δ.

ִ ĸ ȯ 忡 ָ

, ȯ ġ 忡 ĸ پ о߿ Ȱ ִ. FDA 迡 ظ 200 ȯġμ ӻ󰳹 ϰ ֱ εǰ ִ ž 3 1 ȯ ġ з ϰ ִ. ó, ȯ ġ ָ ũٴ ܿ ֱ ̴. ̱ , ٸ ȯ ġ ߿ ҿ ְ NIH κ ޾ ž ߿ ִ ٰ ž û 쿡 ϴ ( 20) ֱ⵵ Ѵ. ϴ žμ Ư Ϲݾ Ǹ 5Ⱓ ִ Ϳ ȯġ 7Ⱓ ش ( Ϻ 10 ).

̷ ÿܿ ȯ ġ ӻ FDA ɻ ð ǰ 鿡 ߰ߵȴ. ֱٿ ǥ ڷḦ , ȯ ġ ӻ Ⱓ 51μ Ϲ ġ 69 ª Ÿ. ȯ ġ ӻ Ư ȯڱ ϴ ȭ ε ο ʿ Ű δ. , ž ɻⰣ Ϲ ž 17 Ϳ ȯ ž 9 ª( ڿ ). ӻ ž ĺ ι޴ Ϲ ž 16% Ϳ ȯ ž 22% Ÿ ִ.

ȯ ġ ϳ ŷ ΰġ ִٴ ̴. ȯ 䵶ı (atypical hemolytic uremic syndrome) Soliris (Alexion) 1 ప 45000̳ Ǿ ߿ ִ Ǿǰ߿ ప δ. ٸ ȯ (ӭ)ı (short bowel syndrome) ϴ Gattex (NPS) 1 ప 33000 ̸. Kalydeco (Vertex) 1 ప 3 Ѿ. , ȯڼ ׷ ߺ ȸϷ ప åɼۿ , ƹ ޴´ٰ ص ȯڿ Ȥ δ Ǵ ȸ ߻Ű ־ ް ִ. ̷ డ ȯ ߻翡 ִ ǰ ֱ⵵ ϴ. ȯ ġ 1⿡ 1 ̻ ø ִ.

ȯ ġ 1 ̻ ÷

׷, ȯ ġ ߿ ũ ũٴ ʿ䰡 ִ. 켱, ȯ ¿ ߿ Ѵ. Ϲȯ ޸ κ ȯ , ߺ, 𵨿 ˷ų Ȯ ͵ ̴. ׸, ȯ ġ ӻ Ϸ FDA κ Ϲ ž ޸ ȯ ž(orphan drug) ޾ƾ Ѵ. ǥ ϴ ȯ ȯ FDA Ȯ ȴ. 1983 2010 踦 ûǼ 30% ȯ ִ. ӻ ۵ Ŀ ӻ ڸ Ȯϴ ȴ. Ư, ͼ ſ ȯ Ȯü ŭ ð üǴ ִ ̴. ϴ ȯڸ Ȯߴ ϴ Ը ӻ ÿ ؾ ϴ ߿ ȿ ͸ Ⱑ .

׻Ӹ ƴ϶, ӻ FDA ɻ޴ ܰ赵  ġĿ ޶ ִ. ȯ ġ ɻⰣ ȴٰ ǻ ɻⰣ ü ª ƴ϶ (ȭ ) ȯ ž Ϲݽɻ (standard review, 12 ҿ)ٴ 켱ɻ (priority review, 6ҿ) ޴ ̴. ֱ 2Ⱓ 㰡 70 ʸ м Ϲ ž ü 30% 켱ɻ縦 ޾Ҵ ݸ鿡 ȯ ž 63% 켱ɻ ִ. , 켱ɻ ޱ FDA ִ ٰ ڷḦ ʿ䰡 ִ. , ȯ ġ ž ޾Ҵ ص ΰ ū ϴ ƴ϶ ̴. ž ž ͺб ̸ ϰų ߸ŵ ϰ ǰ ִ ؼ ȴ.

ŷ° ѱ ȸ絵

ݱ ó, ȯ ġ ŷ ҵ ÿ Ȱ ִ. ׷, ߼ ޷ ڴ ѱ 鵵 ϴٰ Ѵ. ڱ ԵǴ blockbuster žళ ȯ濡 ȯġ nichebuster ʿ䰡 ִٰ . ֱ ȯ ġ ߿ ִ. ı ġ(), 3 캴 ġ (), ũк ġ ٱ⼼ ġ(Ʈ), ź ġ(̼) ľû ֱ ̴. ̵ ๰ ǥ ߵ ̱ Ͽ ۷ι 忡 ֵ ӻ ϸ 󸶵 ۷ι ȯ ġ ö󼭴 ̴.

õ Ѿȸ мȸ Ⱓ žళ߿ ȹ . ̹ ȯ ġ ߷ ڰ ȸ(KASBP) Ҽ ž ڵ FDA Ҽӵ ɻ ȯ ġ Ȳ ɻ Ұ ̴. ȯ ġ ϴ ̽ ϰ ذȿ ̴. ɷ Ȳ ǰ ̸ ѱ 迡 ȯ ġ ߿ ο ȸ DZ .
ϸ (dailypharm@dailypharm.com) ٸ
  • μ
  • īī
  • ̽
  • Ʈ
  • 7
ñ
/home/dailypharm/issueData2017/
ǰ
7
͸ǰ | Ǹǰ߾ Ģ
ݱ

Ǹ ͸ , Ǹ ̸ ̵ ˴ϴ. ͸ ʸ ϸ, ͸ մϴ.

ڹ(-ڴϾ-ʱ ) ˵ ϸ ȸ Խ ⡯ ĺ Ʈ ׻ ֻܿ ˴ϴ. ο ø Ϲȸ Խ ĺ ڴϾ ȸ ϴܿ ǽð ˴ϴ.

뺸 ϰ ̵ ̿ Ǵ ֽϴ.

  • ۱ǡΰݱ Ÿ Ǹ ħϴ

    α׷ ϰ , ȳϴ Խù

    Ÿ Ǵ 3 ۱ Ÿ Ǹ ħ Խù

  • ٰ 桤 Ѽϴ Խù

    Ư ̿ ο ν 弳

    Ư 븳 ϴ

    Ȯ ȵ ҹ Ű

    弳 , Ӿ

    Ź, ɿ ˵Ǵ ( û )

    Ư ̳ ü ϴ

    Ư ѼϿ ش ûϴ

    Ư (ֹεϹȣ, ȭ, ּ ) Խϴ

    Ÿ ID Ȥ г ϴ

  • Խ Ư ѵǴ

    ʴ

    翡 ߺ

    κ Ͽ ݺ ϴ 쵵

    Խù,

    Ե Խù

    Խù б

  • û ִ

  • Ÿ

    ʿ伺 ̸

    Ÿ ˵Ǵ 縦

    Ÿ  ڰ ʿϴٰ ǴܵǴ

  • Ȯ

    ۱ڷκ , , ϴ

    Ÿ ʻ ħϰų ϴ

    翡 ̿ (Ÿ ID, йȣ )

  • ̻ Ϻ ׿ ̿ 縦 , Ρ ó ֽϴ.

    õ ̴ ҹ Ǵܵǰų ϸ 񽺿 ٶ ʴٰ ǴܵǴ ġ ϰڽϴ.

    رŸ ϸ ڿ ֽʽÿ. ּҴ dailypharm@dailypharm.comԴϴ.

ֽż ݴ
  • 2013.04.11 13:36:49 |

    츮󿡼

    ̷ ߵǾ ̿ϱ⸱ ٶϴ ~

    0 0 0
  • 2013.04.11 13:14:33 |

    ÷ۿ

    ʿ о Ǵ ÷~~ ֽø ~

    0 1 0
  • 2013.04.11 09:03:26 |

    ִ

    ѹڻ , ۼؾ, 췯 Į ׻ ٷϴ. Į ø 鼭 žళ ü ִ ҽϴ. Ӹƴ϶ , а  ϴ е о ϴ Դϴ.

    0 0 0
  • 2013.04.10 17:57:12 |

    ȯ...

    Ͷ ൵ ̿ ϰڱ...

    1 0 0
    • 334950
      2013.04.10 18:52:09 |
      ڷῡǰ ۰ Ȯ м մϴ. а ֽϴ^^
  • 2013.04.10 16:01:49 |

    ȳ ߾. ~

    ڽǸ 帮 !! 20 ̻ 10Ʈ 帳ϴ.ѸŴ 2 10о ÷Ͽ 10,000 ǰ 帳ϴ.Ʈ ȸ 5 7Ϻ մϴ.

    0 1 0
  • 2013.04.10 15:35:13

    ȯ~~

    ׷ ־ٴ....ѹڻ ϳ ϴ. ġ Ʈ带 ϴµ ū Ǵ Դϴ. ȸ鵵 ܱ Ŵȸ º ƴ ϴ ġ ͵ ڳ׿.Ư ƽþƱǿ Ѵٵ簡 ϴ ο~~

    0 1 0
  • 2013.04.10 14:12:48 |

    ׻ մϴ.

    ȸ μ ֽ ⿡ ִ δ ʹ ֽϴ. ε Ź帳ϴ.

    0 1 0
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
ü



ͳݽŹϹȣ: 00048 | 2005.09.09 | 2005.09.09 | : | : ȣ
ּ: ı 128 SK V1 GL ƮνƼ A 401ȣ
ȭ : 02-3473-0833 |ѽ : 02-3474-0169 | ûҳ⺸ȣå(å ű)
Contact dailypharm@dailypharm.com for more information
ϸ () ϴ ۱ǹ ˵Ǹ, 縦 ֽϴ.