Benlysta, a Lupus Drug, Is Approved by F.D.A. – NYTimes.com

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.

To check out the Lupus Foundation’s response, click here, and FAQ about the drug, click here.

drug trials

An article in this weekend’s NY Times, “New Drugs Stir Debate on Rules of Clinical Trials,” brings up issues of the current system of clinical drug trials in the US required for FDA approval before hitting the market.  This article looks at PLX4032, a new drug used to shrink melanoma tumors and help improve quality of life, though maybe without extending life expectancy.  Two cousins are at the center of this article, both with melanoma, both in the clinical trial, though one was given the new drug and one was put in the control group, meaning he received standard chemotherapy treatments. The one in the group with the new drug improved and the one that received the control died.

This issue brings to the fore what many doctors in the article say is a dated drug approval system.  There are three phases a drug must pass before FDA approval, each phase with a different set of rules and criteria.

Recently, a new drug for lupus treatment, Benlysta, passed through Phase III, but I still haven’t seen it on the market – supposedly it will be available by the end of the year and will be the “first new approved drug for people living with lupus in more than 50 years” – Benlysta website.  50 years is an extremely long time for those living with this chronic to wait, while in the meantime being treated by drugs originally made as antimalarials – the connection between the antimalarials and positive reaction in lupus patients still being unknown.  Is this system working?  Or is it not?