Navigation Links
Vidaza receives positve opinion from European CHMP

The Aplastic Anemia & MDS International Foundation is pleased to inform patients that the European Committee for Medicinal Products for Human Use (CHMP) has awarded Vidaza (azacitidine) a positive opinion for the treatment of myelodysplastic syndromes (MDS) patients who are not eligible for stem cell transplants.

The CHMP's positive opinion is based on data from the AZA-001 trial, which demonstrated an overall, unprecedented survival benefit for higher-risk MDS patients. The positive opinion will be forwarded to the European Commission that generally follows the recommendation of the CHMP and issues final marketing approval.

"We are excited by Vidaza's positive CHMP opinion because there are few treatment options for patients in Europe with this disease," said John Huber, Executive Director of the Aplastic Anemia & MDS International Foundation, "Vidaza not only extends patients' lives, but also improves their quality of life. We are hopeful that Vidaza will receive marketing approval shortly and quickly be available for patients across Europe."

Myelodysplastic syndromes (MDS) occur when the bone marrow stem cells malfunction. This results in the production of too many defective blood cells and not enough normal cells. Diagnosis is made through blood tests and a bone marrow biopsy. Once diagnosed, treatment and evaluation should occur under the care of a hematologist or hematologists/oncologist. There are many subtypes of MDS classified according to how the disease manifests itself in the blood and marrow of the patient. Treatments include blood transfusions, growth factors, chemotherapy and bone marrow transplant.


Contact: John Huber
Aplastic Anemia & MDS International Foundation

Page: 1

Related biology news :

1. The MDS Foundation supports the FDAs decision to expand vidaza label to include survival data
2. FDA approves Vidaza label expansion
3. Global Viral Forecasting Initiative receives $11M to implement pandemic early warning system
4. Penn State receives new NASA astrobiology grant
5. American College of Medical Genetics receives $13.5M NIH contract
6. Kount Receives Patent for Device Fingerprinting
7. L-1 Identity Solutions Receives $5.9 Million Drivers License Contract Expansion from the State of Mississippi
8. Wistar Institute researcher receives New Innovator award from NIH
9. CCNY receives $5 million NSF grant to establish center for nanostructure applications
10. NYU receives $490k NSF grant to promote women in the sciences
11. Childrens National researcher receives ACCP Distinguished Investigator Award
Post Your Comments:
(Date:6/22/2016)... BETHESDA, Md. , June 22, 2016  The American ... by Trade Show Executive Magazine as one of ... Summit on May 25-27 at the Bellagio in ... based on the highest percentage of growth in each of ... number of exhibiting companies and number of attendees. The 2015 ...
(Date:6/20/2016)... , June 20, 2016 Securus ... justice technology solutions for public safety, investigation, corrections ... the prisons involved, it has secured the final ... (DOC) facilities for Managed Access Systems (MAS) installed. ... additional facilities to be installed by October, 2016. ...
(Date:6/9/2016)... Finland , June 9, 2016 ... National Police deploy Teleste,s video security solution to ensure the ... France during the major tournament ... data communications systems and services, announced today that its video ... Prefecture to back up public safety across the ...
Breaking Biology News(10 mins):
(Date:6/24/2016)... on a range of subjects including policies, debt and investment ... Speaking at a lecture to the Canadian Economics ... the country,s inflation target, which is set by both the ... "In certain areas there needs to be frequent ... not sit down and address strategy together?" He ...
(Date:6/23/2016)... ... June 23, 2016 , ... Mosio, a leader in clinical ... Patient Recruitment and Retention Tips.” Partnering with experienced clinical research professionals, Mosio revisits ... tips, tools, and strategies for clinical researchers. , “The landscape of how patients ...
(Date:6/23/2016)... -- A person commits a crime, and the detective uses ... criminal down. An outbreak of foodborne illness makes ... uses DNA evidence to track down the bacteria that caused ... not. The FDA has increasingly used a complex, cutting-edge technology ... Put as simply as possible, whole genome sequencing is a ...
(Date:6/23/2016)... June, 23, 2016  The Biodesign Challenge (BDC), a ... ways to harness living systems and biotechnology, announced its ... in New York City . ... students, showcased projects at MoMA,s Celeste Bartos Theater during ... , MoMA,s senior curator of architecture and design, and ...
Breaking Biology Technology: