Aa
Aa
A
A
A
Close
7593014 tn?1414212474

is daclatasvir aprooved

Is daclatasvir already aprooved?
3 Responses
Avatar universal
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.
1747881 tn?1546175878
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.

http://news.bms.com/press-release/daclatasvir-marketing-authorization-application-treatment-chronic-hepatitis-c-validate
Avatar universal
European Medicines Agency advises on compassionate use of daclatasvir -
Date of opinion 21/11/2013

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/11/news_detail_001971.jsp&mid=WC0b01ac058004d5c1

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

Excerpts
Compassionate use (with links to specific details pdf files)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000293.jsp&mid=WC0b01ac058007e691

scroll down to
Compassionate-use opinions from the CHMP
Name of medicine Daclatasvir
Have an Answer?

You are reading content posted in the Hepatitis C Community

Top Hepatitis Answerers
317787 tn?1473358451
DC
683231 tn?1467323017
Auburn, WA
Learn About Top Answerers
Didn't find the answer you were looking for?
Ask a question
Answer a few simple questions about your Hep C treatment journey.

Those who qualify may receive up to $100 for their time.
Explore More In Our Hep C Learning Center
image description
Learn about this treatable virus.
image description
Getting tested for this viral infection.
image description
3 key steps to getting on treatment.
image description
4 steps to getting on therapy.
image description
What you need to know about Hep C drugs.
image description
How the drugs might affect you.
image description
These tips may up your chances of a cure.
Popular Resources
Chlamydia, an STI, often has no symptoms, but must be treated.
For people with Obsessive-Compulsive Disorder (OCD), the COVID-19 pandemic can be particularly challenging.
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Here’s how your baby’s growing in your body each week.
These common ADD/ADHD myths could already be hurting your child
This article will tell you more about strength training at home, giving you some options that require little to no equipment.