Food and Drug Administration (FDA) to Hold Hearing on BENLYSTA® on November 16th


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

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, [email protected] by November 1, 2010.

  • Terri

    This is great news for all of us wwho have Lupus. I would be willing to try anything to get rid of both of the autoimmune diseases I have.

  • Desi

    I heard it was an infusion. And that it will definately be costly the first year its out. About 1200. But only because its the first of its kind untill its in generic form. Not sure if its infused monthly or weekly, or what.

  • Jack

    Hi Stacey

    That is good news! Glad the drug is working for you. I have a few questions for you. How is this drug taken? Is it a pill? After 6 years, are you still needing to use the usual meds with benlysta? Any side effects?



  • Stacey Houston

    I have been in this drug study since the beginning. This is my 6th year. I believe I would be in a wheel chair if I wasn’t taking Benlysta! I am so excited it is almost ready to be approved by the FDA.

    Stacey Houston