The first drug since Eisenhower for systemic lupus erythematosus (SLE or lupus for short) has been approved by the FDA. The drug, Benlysta will be marketed under GlaxoSmithKline, but was developed by Human Genome Sciences. The drug was developed through the discovery of a protein, the B lymphocyte stimulator through “sifting through its database of human genes,” that could then be inhibited by a monoclonal antibody – which is the drug Benlysta, or belimumab. This discovery made by exploring human genomic data makes this drug one of the first “to emerge from the genomics revolution.”
Interestingly enough, the drug is administered via intravenous infusion every 28 days, so about every month, and would end up costing around $35,000 a year. With this cost, it seems unlikely that the drug would be administered widely, especially since the cost of steroids and anti-malarials is so cheap. Another complicating factor in this drug approval is that it is not necessarily approved for African-American patients. It was said that African-Americans “did not appear to respond to the drug,” and the FDA claimed that “there were too few African-Americans in the trials to draw a definitive conclusion.”
The discovery and approval of this drug are more socially, racially, economically, and sexually complicated than one might think at first glance. One needs to keep in mind the demographics of the disease: an overwhelming majority of lupus patients are women, and of that number, a majority is African-American or Hispanic. Not to mention the price of the drug – it is hard to imagine that those with severely active or debilitating lupus who might be on disability or can’t work full-time would be able to afford such a drug. The steroid here may win out yet again and the push for newer, costlier, and more effective drugs to treat lupus may dwindle. (And, then, I am not even sure about the complicating factor of human gene research used to create this drug. That seems to bring up a whole other set of issues…)
To read the article printed in the NY Times, click here: Benlysta, a Lupus Drug, Is Approved by F.D.A. – NYTimes.com.