Good explanation of Lupus problem and how Benlysta is thought to be a game changer:
http://www.youtube.com/watch?v=i24UTvOKK-8
1) Normal lupus drugs than suppress the immune system tend to have lots of side effects.
2) Varied presentations of the disease, with lots of up/downs (flare/remission), so its difficult to get a baseline of disease activity for studies. This is a risk that discourages investment in Lupus.
3) Benlysta was the first drug to set the standard criteria for clinical trials to come after with Lupus cohorts.
Now for the point not made in the video which is 2 years old.
4) Despite FDA approval Benlysta was not as effective as hoped, or at least for the large price tag the NHS (UK) had concerns of value for money:
"there were no reliable data to show the relative efficacy of belimumab compared with rituximab. Without this, the Committee could not reach a conclusion as to the cost effectiveness of belimumab compared with rituximab."
(end of post)
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(20min delay)