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Daclatasvir-ART Interactions/FDA review/Phase 3 Studies
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CROI/2012: Assessment of HIV Antiretroviral Drug Interactions With the HCV NS5A Replication Complex Inhibitor Daclatasvir Demonstrates a PK Profile Which Supports Coadministration With Tenofovir, Efavirenz and Atazanavir/r
http://www.natap.org/2012/CROI/croi_38.htm
Bristol-Myers Squibb Submits NDAs for Daclatasvir and Asunaprevir to US FDA for the Treatment of Hepatitis C.....http://www.natap.org/2014/HCV/040814_01.htm
Monday, April 7, 2014 8:00 am EDT
Bristol-Myers Squibb Company (NYSE:BMY) announced today that they have submitted new drug applications (NDAs) with the U.S. Food and Drug Administration (FDA) for the investigational products daclatasvir (DCV) an NS5A replication complex inhibitor and asunaprevir (ASV) a NS3 protease inhibitor. The data submitted in the NDAs support the use of DCV+ASV in patients with genotype 1b hepatitis C (HCV). The DCV NDA also seeks approval for use of this compound in combination with other agents for multiple genotypes. The submissions are subject to FDA review for acceptance for filing.
In January 2014 the European Medicines Agency (EMA) validated the company's marketing authorization application for the use of DCV in combination with other agents for the treatment of adults with HCV with compensated liver disease including genotypes 1 2 3 and 4 and this application is under accelerated review. In addition NDAs for DCV and ASV are under priority review by Japan's Pharmaceutical and Medical Devices Agency for patients with chronic HCV genotype 1b classified as either interferon-ineligible naïve/intolerant or non-responders to interferon and ribavirin.
"These submissions follow the recent announcement that the FDA granted the investigational DCV Dual Regimen (DCV+ASV) Breakthrough Therapy Designation. In 2013 the investigational all-oral 3DAA Regimen (daclatasvir/asunaprevir/BMS-791325) also received Breakthrough Therapy Designation and the company anticipates submitting this regimen for FDA review in Q1 2015."
Daclatasvir+Sofosbuvir - (05/09/14)
Phase III HIV/HCV Co-Infection Daclatasvir (DCV)+ Sofosbuvir (SOF).......in Treatment-naïve and Treatment-experienced Chronic Hepatitis C (Genotype 1, 2, 3, 4, 5, or 6)
Phase III Daclatasvir + Sofosbuvir in Cirrhotic Subjects and Subjects Post-liver Transplant
Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV
EASL/2012: Potent Viral Suppression With the All-Oral Combination of Daclatasvir (NS5A Inhibitor) and GS-7977 (Nucleotide NS5B Inhibitor), +/- Ribavirin, in Treatment-Naive Patients With Chronic HCV GT1, 2, or 3 (100% SVR gt1, 91% gt2) - (04/19/12)
EASL: Sustained Virologic Response With Daclatasvir Plus Sofosbuvir ± Ribavirin (RBV) in Chronic HCV Genotype (GT) 1-Infected Patients Who Previously Failed Telaprevir (TVR) or Boceprevir (BOC) - (04/27/13)
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