October 27, 2010

Food and Drug Administration to Hold Hearing on BENLYSTA®

On November 16, 2010, the Food and Drug Administration (FDA) will hold a hearing to discuss the application to approve BENLYSTA® (belimumab) as a treatment to reduce disease activity in adults with active, autoantibody-positive lupus.

If approved, BENLYSTA® will be the first drug to be specifically developed for lupus and the first new treatment for lupus in more than 50 years.

While BENLYSTA® may not be appropriate for all people with lupus, having a new approved treatment for lupus would be a significant step forward and would provide a pathway for future approval of the arsenal of therapies required to manage a disease as diverse and complex as lupus.

The public is welcome to attend all or portions of the FDA hearing. If you’re in the Washington DC metropolitan area, please consider joining us at the public meeting in College Park, MD. For more information, please visit http://www.fda.gov/AdvisoryCommittees/Calendar/ucm226091.htm.

It is important for the FDA Committee to have a clear understanding of the diversity of the disease and how it impacts people with lupus and their families. You can make your voice heard by sharing your story about why new, safe, effective and more tolerable treatments are needed and the hope for new treatments in the future. Email your short statement to Yvette Waples at the FDA, Yvette.waples@fda.hhs.gov by November 1, 2010.


Anonymous said...

I was diagnosed with Lupus SLE in August 1993 and was told that I probably had it longer but the problems I was having were not diangosed correctly. I am curently taking 19 different medications for Lupus, Sjogrens Syndrome, Lupus induced Migraines and arthritis. I have been lucky so far as the Lupus has not affected any major organs, however, the medications do cause side effects, and new drug therapies are needed that don't have possible liver, kidney damage. I fear that some time in the future the drugs I am taking will take a toll on my kidneys or liver with toxic levels. Research needs to continue for Lupus just as it does for cancer so that hopefully some day in the near future there will be a cure.

Anonymous said...

I would really like to see better test's done in diagnosing LUPUS.It is good that there could be a new drug in the treatment of Lupus