ABC
1Main
2Brand NameBenlysta
3Generic Namebelimumab
4IndicationSLE
5Timeline11/16/2010 AdCom recommended approval.
6Clinical Trials
7Phase III BLISS-76
8Met primary endpoint of responser rate versus placebo.
938.5%, 39.1% and 32.4% for 10mg, 1mg and placebo. P=0.13, 0.11 at 76 weeks.
1010mg group met its primary with 43.2% response, 40.6% for 1mg and 33.8% for placebo, p=0.021, p=0.10.
11
12Phase III BLISS-52
1357.6% for 10mg, 51.7% for 1mg and 43.6% for placebo response rates, p=0.0006, p=0.011.