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Food and Drug Administration to Hold Hearing on BENLYSTA®

Posted Oct 27 2010 10:08am
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.
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