Lupus Foundation of America Applauds FDA's Decision to Approve Benlysta®

First new treatment for lupus in more than 52 years

(Washington, DC, March 9, 2011) Today, the U.S. Food and Drug Administration (FDA) approved the drug, BENLYSTA®, for the treatment of lupus, an autoimmune disease.

Sandra C. Raymond, President and Chief Executive Officer of the Lupus Foundation of America (LFA), has issued the following statement regarding the FDA’s decision:

“This is a historic day for the millions of people with lupus and their families around the world who have waited more than 52 years for a treatment breakthrough for lupus. We at the LFA applaud the FDA’s decision to approve BENLYSTA®. BENLYSTA is the first drug ever to be specifically developed to treat lupus, and is a significant first step toward reaching our goal of developing an arsenal of new, safe, effective, and tolerable treatments. Today marks the beginning of a new era of improved diagnosis, prevention, and treatment for the disease.

“The LFA wishes to thank the physicians, researchers, industry leaders, and the many study volunteers who made this day possible. We also extend a special thank you to BENLYSTA®’s developers, the staff of Human Genome Sciences and GlaxoSmithKline, who have long been committed to the research and development process. These efforts will go a long way in elevating the profile of this disease that remains a significant national public health problem.

“There are a number of pioneering biotechnology and pharmaceutical companies, involved in the research and development of new treatments for lupus, and our hope is that today’s decision will further stimulate additional companies to invest in new therapies for lupus. To build on this momentum and encourage the development of new treatments, the LFA has launched new initiatives that help to strengthen clinical trials. These programs include the launch of a Web-based program designed to train clinical investigators on the instruments used in trials. As well, the LFA recently implemented the LFA Lupus Research Registry which enables individuals to be notified about new clinical trials in their geographic area. The Registry is part of the LFA’s Center for Clinical Trials Education.

“The LFA also is partnering with key stakeholders from industry, government, and the scientific community to evaluate data from previous lupus clinical trials with the goal to improve the design of future studies."

Additional Resources

• What does having a new treatment for lupus mean to you? Read some stories now.
  
  
• Learn LFA answers to Frequently Asked Questions about BENLYSTA®
  
  
• Read the Human Genome Sciences announcement about BENLYSTA®
  
  
• Read the FDA press release about the approval of BENLYSTA®
  
  
• Help develop a full arsenal of safe, effective, and tolerable treatments. Learn about participating in future lupus clinical trials.
  
  
• Ensure proper government funding is provided for lupus research and education initiatives. Register to become a lupus e-advocate.
  
  
• Band Together for lupus. Wear your purple wristband to help raise awareness of lupus and support those affected by the disease.

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