분자유전학실험실 (단국대학교 분자생물학과)



 이성욱 ( 2014-11-26 16:14:02 , Hit : 1284
 EMA panel recommends approval of DAA regimen for patients with HCV

November 21, 2014


The European Committee for Medicinal Products for Human Use, or CHMP, granted a positive opinion for the recommendation of Viekirax plus Exviera, with or without ribavirin, for the treatment of chronic hepatitis C genotype 1 and 4 infection, according to a press release.

  

See Also
EMA committee recommends Harvoni to treat HCV ...
Dynavax withdraws European marketing application for ...
PEARL-II, III: High SVR rates met in HCV genotype 1b patients ...
  
Featured

Liver Meeting 2014
ACG 2014
EASL 2014

Highlights from The Liver Meeting 2014
Highlights from ACG 2014
Highlights from DDW 2014
Highlights from EASL 2014

The Viekirax (omitasvir/paritaprevir/ritonavir, AbbVie) and exviera (dasabuvir, AbbVie) combination was looked upon favorably based on data from multiple phase 3 studies — SAPPHIRE-I, SAPPHIRE-II, PEARL-II, PEARL-III, PEARL-IV and TURQUOISE-II. The CHMP’s recommendation will be addressed by the European Commission, which has the authority to approve the drug for the European Union. More than 2,300 patients have been included in the studies with the direct-acting antiviral regimen, and the treatment has been generally well tolerated.

“The CHMP positive opinions mark an important milestone in our HCV development program and recognizes the potential our treatment brings to people in Europe living with this chronic condition,” Michael Severino, MD, executive vice president of research and development and chief scientific officer of AbbVie, said in the press release. “Our treatment has been developed with the goal of achieving high cure rates in a broad range of genotype 1 patients with low rates of discontinuation and relapse.”

The all-oral, interferon-free regimen consists of a fixed-dose combination of the protease inhibitor ritonavir, at 100 mg/150 mg, co-formulated with 25 mg ombitasvir, administered once daily, along with 250 mg dasabuvir with or without ribavirin, administered twice daily. The European Medicines Agency (EMA) has granted accelerated assessment for the combination treatment. If approved, the regimen will be available for marketing in all 28 European Union member states.

AbbVie submitted a new drug application for the investigational treatment to the FDA in April. The FDA assigned the treatment breakthrough therapy designation in May 2013, granting it priority review.







827   텔로머레이즈 기반 유전자 요법으로 심장마비 치료  이성욱 2014/12/24 1669
826   일본의 검증팀 STAP 세포 재현 포기, 오보카타 사임  이성욱 2014/12/23 1077
825   아수라장 속에서 탄생한 생명  이성욱 2014/12/17 1240
824   암 생존율을 높일 수 있는 면역세포  이성욱 2014/12/16 1095
823   FDA approves 9-valent HPV vaccine for certain cancers  이성욱 2014/12/12 1144
822   C형 간염 치료에서 비용 효율성을 보인 시메프레비르(simeprevir) 기반 요법  이성욱 2014/12/11 1723
821   Y 염색체 상실을 초래할 수 있는 흡연  이성욱 2014/12/10 1344
820   술의 역사: 영장류가 진화한 것은 알코올 섭취능력 때문?  이성욱 2014/12/04 1272
819   혈우병 환자들에게 안전성과 효과를 입증한 유전자 요법  이성욱 2014/11/27 1617
  EMA panel recommends approval of DAA regimen for patients with HCV  이성욱 2014/11/26 1284
817   AMD를 치료하는데 사용될 수 있는 HIV/AIDS 약물들  이성욱 2014/11/26 1394
816   인간과 생쥐 유전체의 유사성과 차이점  이성욱 2014/11/25 1924
815   Cost to Develop a Drug More Than Doubles to $2.56 Billion  이성욱 2014/11/21 1129
814   세균과 싸우도록 자극하면, 바이러스까지도 물리치는 세포  이성욱 2014/11/20 1495
813   Gilead wins European approval of next-generation hepatitis C drug  이성욱 2014/11/20 1162
812   [바이오토픽] 표준 인간 게놈지도의 갭을 메워라: 플래티넘 게놈지도 탄생  이성욱 2014/11/19 1603
811   종양 내에서 T 세포 면역에 핵심적인 항원제시 세포  이성욱 2014/11/17 1665
810   AbbVie, Enanta drug shows potential in hep C genotype 4 patients  이성욱 2014/11/15 1188
809   Gilead hepatitis C drug highly effective in cirrhosis patients  이성욱 2014/11/14 1068
808   새로운 HIV/AIDS 치료법 개발  이성욱 2014/11/14 1472

[이전 10개] [1]..[21][22] 23 [24][25][26][27][28][29][30]..[64] [다음 10개]
 

Copyright 1999-2021 Zeroboard / skin by ROBIN