Thanks for the welcome Tig. I've lurked here for over a year....knew I had the answer to the original poster so made the jump and registered.
I'll tell my story in the new member section. Thanks again!
Tig said
Nov 8, 2014
Hello PJ,
Welcome to the forum! Thanks for the information on Daclatasvir. I recommend you do a search of our search page, there you will find several threads and comments on the topic as well. There have been some very good reports recently and we look forward to all the recent additions to the battle!
Let us know a little about yourself when you have time. Feel free to introduce yourself in our new members section! We've got a great group and look forward to hearing more from you! Good luck...
EU commission approves daclatasvir for multiple genotypes
August 27, 2014 European Commission Approves Bristol-Myers Squibbs Daklinza (daclatasvir) Across Multiple Genotypes for the Treatment of Chronic Hepatitis C Infection
Daklinza, when used in combination with sofosbuvir, is an all-oral, once daily regimen that yields cure rates of up to 100%
Daklinza + sofosbuvir offers potential cure for a broad range of EU HCV patients, including those with advanced liver disease, genotype 3 and protease inhibitor failures
"The eradication of HCV is in sight, and with todays approval, Daklinza, in combination with other agents, will be an important option to achieve cure across many HCV genotypes and patient types for those in the EU who are in dire need of new treatment choices"
"We anticipate that, if approved, Daklinza-based regimens will play a significant role in treating HCV patients with high unmet medical needs across Europe."PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Daklinza® (daclatasvir), an investigational, potent pan-genotypic NS5A complex inhibitor (in vitro), be granted approval for use in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults. This is the first positive opinion given by the CHMP for an NS5A complex inhibitor and will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU).
Through Bristol-Myers Squibbs Early Access Programs in Europe more than 2,000 HCV patients with advanced liver disease have already been treated with Daklinza, in combination with sofosbuvir, said Elliott Levy, Head of Specialty Development, Bristol-Myers Squibb. We anticipate that, if approved, Daklinza-based regimens will play a significant role in treating HCV patients with high unmet medical needs across Europe.
Recently included in the European Association for the Study of the Livers (EASL) clinical practice guidelines for the management of HCV infection across genotypes, the EU marketing authorization application for Daklinza has gonethrough an accelerated review process. The positive CHMP opinion was based on data from multiple studies ofDaklinza with other HCV agents, including sofosbuvir, for the treatment of chronic hepatitis C.
Applications for Daklinza-based regimens are also pending in Japan and the U.S. A decision from Japans Pharmaceutical and Medical Devices Agency is expected soon, and the U.S. Food and Drug Administration has granted priority review status and set a target review date under the Prescription Drug User Fee Act (PDUFA) of November 30, 2014.
Ongoing and completed Daklinza studies have included more than 5,500 patients in a variety of all-oral regimens and with the current interferon-based standard of care. Across clinical studies, Daklinza-based regimens have been generally well tolerated with low rates of discontinuations across a range of patients.
-- Edited by pamelajean on Saturday 8th of November 2014 03:01:35 PM
Angel67 said
Nov 8, 2014
Probably way before it gets approved in England!
Lon said
Nov 8, 2014
Hello,
Has anyone heard when Daclatasvir will be approved in the US?
Thanks for the welcome Tig. I've lurked here for over a year....knew I had the answer to the original poster so made the jump and registered.
I'll tell my story in the new member section. Thanks again!
Hello PJ,
Welcome to the forum! Thanks for the information on Daclatasvir. I recommend you do a search of our search page, there you will find several threads and comments on the topic as well. There have been some very good reports recently and we look forward to all the recent additions to the battle!
Let us know a little about yourself when you have time. Feel free to introduce yourself in our new members section! We've got a great group and look forward to hearing more from you! Good luck...
Tig
http://www.hepctrust.org.uk/News_Resources/news/2014/September/EU+commission+approves+daclatasvir+for+multiple+genotypes
EU commission approves daclatasvir for multiple genotypes
August 27, 2014
European Commission Approves Bristol-Myers Squibbs Daklinza (daclatasvir) Across Multiple Genotypes for the Treatment of Chronic Hepatitis C Infection
Daklinza, when used in combination with sofosbuvir, is an all-oral, once daily regimen that yields cure rates of up to 100%
Daklinza + sofosbuvir offers potential cure for a broad range of EU HCV patients, including those with advanced liver disease, genotype 3 and protease inhibitor failures
"The eradication of HCV is in sight, and with todays approval, Daklinza, in combination with other agents, will be an important option to achieve cure across many HCV genotypes and patient types for those in the EU who are in dire need of new treatment choices"
Through Bristol-Myers Squibbs Early Access Programs in Europe more than 2,000 HCV patients with advanced liver disease have already been treated with Daklinza, in combination with sofosbuvir, said Elliott Levy, Head of Specialty Development, Bristol-Myers Squibb. We anticipate that, if approved, Daklinza-based regimens will play a significant role in treating HCV patients with high unmet medical needs across Europe.
Recently included in the European Association for the Study of the Livers (EASL) clinical practice guidelines for the management of HCV infection across genotypes, the EU marketing authorization application for Daklinza has gone through an accelerated review process. The positive CHMP opinion was based on data from multiple studies ofDaklinza with other HCV agents, including sofosbuvir, for the treatment of chronic hepatitis C.
Applications for Daklinza-based regimens are also pending in Japan and the U.S. A decision from Japans Pharmaceutical and Medical Devices Agency is expected soon, and the U.S. Food and Drug Administration has granted priority review status and set a target review date under the Prescription Drug User Fee Act (PDUFA) of November 30, 2014.
Ongoing and completed Daklinza studies have included more than 5,500 patients in a variety of all-oral regimens and with the current interferon-based standard of care. Across clinical studies, Daklinza-based regimens have been generally well tolerated with low rates of discontinuations across a range of patients.
-- Edited by pamelajean on Saturday 8th of November 2014 03:01:35 PM
Hello,
Has anyone heard when Daclatasvir will be approved in the US?
Thanks,
Lon