An FDA advisory panel is considering today if they will recommend Benlysta for FDA approval. You may want to do a quick search for up-to-date information. I read that there were some concerns that there were some side effects resulting in depression and suicide, but many of those involved in the trials were also taking antidepressants.
I hope that it’s approved and my wife gets a chance to try this.
If you get any additional information, please post it in the comments.
The Committee voted 13 to 2 to recommend approval.
So, it’s been approved? Officially? I can’t seem to find any reports if I Google it.
It hasn’t been approved yet. The advisory panel recommended it for approval; however, the date for formal approval has been moved forward to March 2011.
I have been keeping an eye on Benlysta. I was dx’d with Lupus 10 years ago and have a fairly aggressive form. I have high hopes for this new drug! It’s either this or chemo for me at this point. I truly hope it works!!
Depression and suicide?!! How on earth did they discover such a reaction? A bit worrying, but I suppose there are always slightly alarming facts to consider about every medication in existence.
I am on Rituximab myself, which is also a biologic monoclonal antibody. And yes, it is definitely a better answer than steroids or immunosuppression, in my opinion.
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