Not yet. Was approved on an emergency basis for a single patient who had a liver transplant and reoccurence of the virus in the new liver.
Wednesday, January 8, 2014 7:00 am EST
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that the European Medicines Agency (EMA) has validated the company’s marketing authorization application (MAA) for the use of daclatasvir (DCV), an investigational NS5A complex inhibitor, for the treatment of adults with chronic hepatitis C (HCV) with compensated liver disease, including genotypes 1, 2, 3, and 4. The application seeks the approval of daclatasvir for use in combination with other agents, including sofosbuvir, for the treatment of chronic hepatitis C. The MAA validation marks the start of an accelerated regulatory review process for DCV, which has the potential, when used in combination with other agents, to address a high unmet need in the European Union (EU), where an estimated 9 million people are living with hepatitis C.
European Medicines Agency advises on compassionate use of daclatasvir -
Date of opinion 21/11/2013
Opinion concerns use in combination with sofosbuvir in patients with chronic hepatitis C in urgent need of therapy to prevent progression of liver disease
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given an opinion on the use of daclatasvir in combination with sofosbuvir in the treatment of chronic (long-term) hepatitis C virus (HCV) infection, in a compassionate-use programme
Compassionate use (with links to specific details pdf files)
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Compassionate-use opinions from the CHMP
Name of medicine Daclatasvir