Discussion Topic
Updated Tysabri LABEL Chaned release today, for the US FDA.
Posted on 11/06/09, 11:10 pm
Article on it...
Lines from the article, I haven't seen the FDA announcement yet.The link to the article about it is below this line.....
http://www.nasdaq.com/aspx/stock-m...
Imteresting lines from the article are below..
By Thomas Gryta, Of DOW JONES NEWSWIRES
NEW YORK -(Dow Jones)- Biogen Idec Inc. (BIIB) amended the U.S. label of multiple sclerosis treatment Tysabri, sold with Elan Corp. PLC (ELN), on Friday to reflect that the risk of a rare brain infection rises with longer usage.
The changes, which were expected, note that the occurrence of progressive multifocal leukoencephalopathy, or PML, in patients treated for 24 to 36 months is "generally similar" to the 1-in-1,000 rate seen in clinical trials. The changes warn that there is limited experience with the drug beyond three years of treatment.
Aside from duration information, the updated label includes details on using plasma-exchange therapy, which removes large molecules from the body's blood circulation, thereby accelerating removal of Tysabri and theoretically improving the immune response to PML infection.
It also explains that inflammation of the rebuilding of the immune system can occur following discontinuation of Tysabri in patients with PML.
The label update comes after 24 cases of PML, including four deaths, have been confirmed in Tysabri patients since it was removed from the market for 18 months beginning in 2005 because of a link to PML, including two other deaths.
Lines from the article, I haven't seen the FDA announcement yet.The link to the article about it is below this line.....
http://www.nasdaq.com/aspx/stock-m...
Imteresting lines from the article are below..
By Thomas Gryta, Of DOW JONES NEWSWIRES
NEW YORK -(Dow Jones)- Biogen Idec Inc. (BIIB) amended the U.S. label of multiple sclerosis treatment Tysabri, sold with Elan Corp. PLC (ELN), on Friday to reflect that the risk of a rare brain infection rises with longer usage.
The changes, which were expected, note that the occurrence of progressive multifocal leukoencephalopathy, or PML, in patients treated for 24 to 36 months is "generally similar" to the 1-in-1,000 rate seen in clinical trials. The changes warn that there is limited experience with the drug beyond three years of treatment.
Aside from duration information, the updated label includes details on using plasma-exchange therapy, which removes large molecules from the body's blood circulation, thereby accelerating removal of Tysabri and theoretically improving the immune response to PML infection.
It also explains that inflammation of the rebuilding of the immune system can occur following discontinuation of Tysabri in patients with PML.
The label update comes after 24 cases of PML, including four deaths, have been confirmed in Tysabri patients since it was removed from the market for 18 months beginning in 2005 because of a link to PML, including two other deaths.
Welcome
Join This Group
A place for users of Tysabri to discuss issue of Tysabri Use and also those interested in starting Tysabri.
