Mar. 09, 2011

LFA Applauds FDA Decision to Approve Benlysta for the Treatment of Lupus

March 09, 2011


(Washington, DC) 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.”

About the LFA’s National Research Program
The LFA’s National Research Program: Bringing Down the Barriers®, is dedicated to addressing research issues that have for decades obstructed basic biomedical, clinical, epidemiological, behavioral, and translational lupus research. The LFA’s approach to research is unique because it directs its funding to areas of research where gaps exist in the understanding of lupus, and to promising areas of study in which other public and private organizations have not focused their efforts. Using a three-pronged strategy, the LFA and its national network are committed to advancing the science and medicine of lupus by: directly funding research to close the gaps in lupus research; advocating for expanded investment in research from public and private sources; leading special initiatives and forging collaborative efforts among stakeholders to address critical issues to advancing the science and medicine of lupus. For more information about the LFA’s National Research Program, visit www.lupus.org/research.


Visit the Benlysta Information page for links to additional information and resources


LFA Resources for Media Regarding FDA Decision on Benlysta®


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