European Commission Approves Daklinza (daclatasvir) Across Multiple Genotypes
Loopy Lisa said
Sep 4, 2014
I hope they blow Solvadi to the wind....greedy company!
Tig said
Sep 4, 2014
Thanks for the great post Jill! Excellent advance across the EU and I hope we can see the costs of this, as well as that of the associated drugs reduced to an affordable level. I want to see what Gilead will do when they counter with Ledispavir next month. This is going to be a battle between Big Pharm at it's ugliest level....
Tig
Cinnamon Girl said
Sep 4, 2014
Wednesday, August 27, PRINCETON, N.J. - Bristol-Myers Squibb today announced that the European Commission has approved Daklinza (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor, for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C in adults. Daklinza, when used in combination with sofosbuvir, is an all-oral, interferon-free regimen that provided cure rates of up to 100% in clinical trials, including patients with advanced liver disease, genotype 3 and those who have previously failed treatment with protease inhibitors. Daklinza is the first NS5A complex inhibitor approved in the European Union (EU) and will be available for use in combination with other medicinal products, providing a shorter treatment duration (12 or 24 weeks) compared to 48 weeks of treatment with interferon- and ribavirin-based regimens.
Today`s approval allows for the marketing of Daklinza in all 28 Member States of the EU. The marketing authorization for Daklinza follows an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP), a designation that is granted to new medicines of major public health interest.
Note - Commercial availability of Daklinza in the EU will be determined by individual Member States.
Link to full press release, including recommended treatment regimens and durations...
I hope they blow Solvadi to the wind....greedy company!
Thanks for the great post Jill! Excellent advance across the EU and I hope we can see the costs of this, as well as that of the associated drugs reduced to an affordable level. I want to see what Gilead will do when they counter with Ledispavir next month. This is going to be a battle between Big Pharm at it's ugliest level....
Tig
Wednesday, August 27, PRINCETON, N.J. - Bristol-Myers Squibb today announced that the European Commission has approved Daklinza (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor, for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C in adults. Daklinza, when used in combination with sofosbuvir, is an all-oral, interferon-free regimen that provided cure rates of up to 100% in clinical trials, including patients with advanced liver disease, genotype 3 and those who have previously failed treatment with protease inhibitors. Daklinza is the first NS5A complex inhibitor approved in the European Union (EU) and will be available for use in combination with other medicinal products, providing a shorter treatment duration (12 or 24 weeks) compared to 48 weeks of treatment with interferon- and ribavirin-based regimens.
Today`s approval allows for the marketing of Daklinza in all 28 Member States of the EU. The marketing authorization for Daklinza follows an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP), a designation that is granted to new medicines of major public health interest.
Note - Commercial availability of Daklinza in the EU will be determined by individual Member States.
Link to full press release, including recommended treatment regimens and durations...
http://news.bms.com/press-release/rd-news/european-commission-approves-bristol-myers-squibbs-daklinza-daclatasvir-across