Multiple Sclerosis (MS) Support Group
This community is a place where members can discuss current events and weigh in on what's going on in the world.
Most of you know this drug was due to be released Jan 2013. I learned on the Wheelchair Kamkazee Blog (author Marc J. Stecker) why its been delayed until March.
His blog states "The experimental oral MS drug BG 12 has also been shown to be quite effective in late stage trials, and was submitted to the FDA for approval (click here). Since the trials had shown the drug to have a very good safety profile, it was a surprise when the FDA extended its review process on BG 12 (click here). I was wondering what might have prompted that action when I came across this article (click here), which tells of a drug called Reata, which was being tested for use against kidney disease and shares the same molecular target as BG 12. Reata had its clinical trials abruptly halted because of serious side effects and even mortality among test subjects. Although the two drugs do share a common molecular target, they work in very different ways, so BG 12 quite likely wont suffer the same fate as Reata, but better safe than sorry. Although the reason for the FDAs extension in reviewing BG 12 has not been made public, I can only imagine that the problems with Reata might be the cause."
Just an fyi for everyone
http://www.wheelchairkamikaze.com/
Melanie
His blog states "The experimental oral MS drug BG 12 has also been shown to be quite effective in late stage trials, and was submitted to the FDA for approval (click here). Since the trials had shown the drug to have a very good safety profile, it was a surprise when the FDA extended its review process on BG 12 (click here). I was wondering what might have prompted that action when I came across this article (click here), which tells of a drug called Reata, which was being tested for use against kidney disease and shares the same molecular target as BG 12. Reata had its clinical trials abruptly halted because of serious side effects and even mortality among test subjects. Although the two drugs do share a common molecular target, they work in very different ways, so BG 12 quite likely wont suffer the same fate as Reata, but better safe than sorry. Although the reason for the FDAs extension in reviewing BG 12 has not been made public, I can only imagine that the problems with Reata might be the cause."
Just an fyi for everyone
http://www.wheelchairkamikaze.com/
Melanie
I took mt last infusion of Tysabri last month
I've been on Tysabri for 3.5 years so my Nuero and other nuero's in his practice said they are no longer treating Tysabri for J C V positive patients! I fall into that category.
Since Tysabri stays in your system for three months I'm hoping on the release of BG-12 in march 2013
I've never NOT been on DMD since I was DXD'd in 2003
I did go on the suggested 3 month drug holiday last year with no increased MS a ctivity! But beyond 4 months for the release of BG-12 who knows!
By the way, thank you Melanie for the heads up!
Chris