분자유전학실험실 (단국대학교 분자생물학과)



 이성욱 ( 2014-11-26 16:14:02 , Hit : 1283
 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.







1107   Dynamic view of the MS genome  이성욱 2010/05/01 2717
1106   Early-Earth cells modeled to show how first life forms might have packaged RNA  이성욱 2012/10/16 2515
1105   Editas Expands CRISPR Capabilities through New Technology Licensing  이성욱 2016/12/22 821
1104   Efficient Process Using microRNA Converts Human Skin Cells Into Neurons  이성욱 2011/07/19 2238
1103   Electronics Giant Samsung Makes First Big Biotech Play  이성욱 2013/02/22 3165
  EMA panel recommends approval of DAA regimen for patients with HCV  이성욱 2014/11/26 1283
1101   Embryonic stem cells improve vision for two women  이성욱 2012/01/25 2336
1100   Engineered Human Liver Tissue Grows in Mice  이성욱 2017/07/25 781
1099   Engineered Viruses Selectively Kill Cancer Cells  이성욱 2011/09/02 2445
1098   Engineering Better Immune Cells  이성욱 2010/05/06 2700
1097   EU, 2번째 유전자치료제 ‘스트림벨리스’ 승인  이성욱 2016/09/05 1147
1096   European regulators back first gene therapy drug  이성욱 2012/07/24 2669
1095   Exosomes Linked to Cancer Spread from Chemoresistant Tumors in Mice  이성욱 2019/01/15 779
1094   Expanding the reach of gene editing with a new CRISPR enzyme  이성욱 2018/10/26 399
1093   Experimental Hepatitis C Drug Shows Promise for Preventing Recurrence in Liver Transplant Patients  이성욱 2013/11/06 2134
1092   Experts find rogue stem cells in liver cancer  이성욱 2011/07/09 2571
1091   Fathers Can Pass Mitochondrial DNA to Children  이성욱 2018/12/26 796
1090   FDA approves 9-valent HPV vaccine for certain cancers  이성욱 2014/12/12 1142
1089   FDA Approves First Gene Therapy for Inherited Disease  이성욱 2017/12/22 512
1088   FDA Approves Gilead CAR-T Therapy Yescarta, Plans Regenerative Medicine Policy 'Soon'  이성욱 2017/10/20 609

[1][2][3][4][5][6][7][8] 9 [10]..[64] [다음 10개]
 

Copyright 1999-2021 Zeroboard / skin by ROBIN