Experimental HCV Drugs
Experimental HCV Drugs
European Regulators Give Positive Opinion on Daclatasvir for Hepatitis C
- Details
- Category: Experimental HCV Drugs
- Published on Friday, 27 June 2014 00:00
- Written by Bristol-Myers Squibb
Bristol-Myers Squibb announced this week that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of its hepatitis C virus (HCV) NS5A inhibitor daclatasvir, which has been given the brand name Daklinza.
AbbVie's 3D Hepatitis C Combo Gets Priority Review in U.S. and Europe
- Details
- Category: Experimental HCV Drugs
- Published on Thursday, 19 June 2014 00:00
- Written by AbbVie
AbbVie's all-oral 3-drug combination regimen for genotype 1 chronic hepatitis C has been granted priority review status by the U.S. Food and Drug Administration (FDA), putting it on track for approval by the end of the year. In related news, the company announced last week that Marketing Authorization Applications for the 3D regimen have been validated and are under accelerated assessment by the European Medicines Agency (EMA), with a decision expected in early 2015.
Daclatasvir + Asunaprevir Is Highly Effective Against Hepatitis C Genotype 1b
- Details
- Category: Experimental HCV Drugs
- Published on Wednesday, 11 June 2014 00:00
- Written by Liz Highleyman
An all-oral combination of daclatasvir plus asunaprevir, without pegylated interferon or ribavirin, cured 87% of genotype 1b patients who were ineligible for or could not tolerate interferon and 81% of prior non-responders in a Japanese study published in the June 2014 edition of Hepatology.
Sofosbuvir/Ledipasvir Cures 100% of Genotype 1 Hepatitis C Patients in Japanese Study
- Details
- Category: Experimental HCV Drugs
- Published on Thursday, 19 June 2014 00:00
- Written by Gilead
All treatment-naive and previously treated participants using a combination pill containing Gilead Science's hepatitis C virus (HCV) polymerase inhibitor sofosbuvir (Sovaldi) and NS5A inhibitor ledipasvir, without ribavirin, for 12 weeks achieved sustained virological response in a Phase 3 study in Japan, where most hepatitis C patients have HCV genotype 1b.
HCV Drug Development: Merck Acquires Idenix, FDA Lifts Sovaprevir Hold
- Details
- Category: Experimental HCV Drugs
- Published on Wednesday, 11 June 2014 00:00
- Written by Merck, Achillion
Merck this week announced that it will purchase Idenix, a specialty biopharmaceutical company developing several hepatitis C virus (HCV) drug candidates. In related news, Achillion announced that the U.S. Food and Drug Administration (FDA) has lifted a clinical hold on one of its drugs and a clinical trial of another is now underway.
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