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March 10, 2011
Benlysta for Lupus
Congratulations to Human Genome Science (and their partners, GSK) for getting the first new lupus drug in 50 years through to approval. It has not been an easy road for Benlysta (belimumab), to put it lightly. Back in 2005, for example, the drug missed its endpoints in Phase II, and things didn't look good.
Further work in the clinic did eventually show a benefit for the antibody, which goes after the B-lymphocyte stimulator protein. But it's not a home run. The FDA advisory committee cleared the drug, but expressed concerns about how effective it really is. The placebo response rate in the trials was rather high, reflecting the difficult clinical presentation of lupus, and that certainly cut into the significance of the final numbers.
But in the end, it does seem to help, and there's been nothing else for so long, and thus approval. How long did all this take? HGS announced that they were starting work in the area back in 2000, a different world compared to today (and especially for them; just look at the long-term stock charts). Did it cost $43 million to develop, as we've been assured is a good estimate for such things? Are you kidding?
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