| Thursday, July 06, 2006
| Tysabri.....dum dum dum!
|Name: Tysabri, Natalizumab (previously known as Antegren)
Marketed By: Biogen Idec Incorporated and Elan Corporation
Intended Use: For the treatment of relapsing-remitting MS, lupus, Crohn's disease, rheumatoid arthritis, and melanoma.
Profile of User: A person afflicted with any of the autoimmune diseases listed above or with melanoma.
What It Is: A monoclonal antibody (a protein naturally found in the body that is produced by the immune system in response to foreign substances), that is bioengineered from part of a mouse antibody that closely resembles a human antibody.
How It Works: By preventing T-Cells (immune cells) from binding to epithelial cells (blood vessel linings) and entering the brain, where nerve cells are attacked, the gastrointestinal tract and joints.
• In 1988 Dr. Elizabeth Wayner began investigating whether or not T-cells adhered to epithelial cells at Dr. Bill Carter's Basic Sciences Division laboratory. The binding of T-cells to epithelial tissue would explain how these immune cells could attack the body’s own tissues, which is what happens in autoimmune disorders, including MS.
• Dr. Wayner develops an antibody that specifically interferes with the T-cell’s ability to bind to epithelial cells. This antibody interferes with the T cell's ability to bind to blood-vessel linings.
• In 2000, Biogen and Elan begin developing Tysabri and begin clinical trials. Tests showed there to be a 67% reduction rate of relapses in patients with RRMS.
• November 2004, Tysabri receives accelerated approval from the FDA.
• March 28, 2005, Tysabri is removed from the market after three cases of multifocal leukoncephalopathy (a usually fatal demyelination disease) is confirmed in trial participants. Two of those patients died.
• In March 2006, three more Tysabri trials wrap up and report the drug to be highly effective and the development of multifocal leukoncephalopathy to be a rare side effect.
• March 8, 2006, FDA panel votes to re-approve Tysabri for the market.
• The US FDA decides to extend its review of Tysabri by 90 days until June 28th 2006.
• Tysabri is not yet approved in Canada.
Benefits: Reduces relapse rate by up to two-thirds after two years of treatment and significantly slows the progression of MS.
Administration: Intravenously every 4 weeks.
Cost: $1,808 USD for each dose. $23,504 USD per year. As it is not approved in Canada yet, the price and coverage is yet to be determined.
• Urinary tract infections
• Joint pain
• Stomach ache
• Depression and errrr there was those two deaths which took it off the market for 3 months but its ok now!
• Cough (lower respiratory tract infections)
• Serious or life threatening allergic reactions
• Multifocal leukoncephalopathy
Just for your info!
I have returned to parents for a long weekend as the heat is kicking my ass! I will be back soon honest! Havent heard from jen for about 6 days now as she has lost her phone....oh well it was great while it lasted! Love you babe!xxxx
Hope you are all well and enjoying these updates!(music will be back soon,got any requests?)
Love and hugs
|posted by personallog! @ 5:16 pm