| A | B | C | |
|---|---|---|---|
| 1 | Main | ||
| 2 | Brand Name | Benlysta | |
| 3 | Generic Name | belimumab | |
| 4 | Indication | SLE | |
| 5 | Timeline | 11/16/2010 AdCom recommended approval. | |
| 6 | Clinical Trials | ||
| 7 | Phase III BLISS-76 | ||
| 8 | Met primary endpoint of responser rate versus placebo. | ||
| 9 | 38.5%, 39.1% and 32.4% for 10mg, 1mg and placebo. P=0.13, 0.11 at 76 weeks. | ||
| 10 | 10mg group met its primary with 43.2% response, 40.6% for 1mg and 33.8% for placebo, p=0.021, p=0.10. | ||
| 11 | |||
| 12 | Phase III BLISS-52 | ||
| 13 | 57.6% for 10mg, 51.7% for 1mg and 43.6% for placebo response rates, p=0.0006, p=0.011. |