I am thrilled that the FDA has chosen to approve the use of BENLYSTA as a treatment for lupus. This milestone has been a long time coming and to lupus survivors all over the country. It is a time of renewed hope and an optimism for the future that has been elusive. As a patient living with lupus for over 40 years, I am emotionally ecstatic and overwhelmed by the series of the events that will now follow with this gate opener to bringing down the barriers of the treatments of lupus. I praise God for the mission he embarked on my life in the world of lupus and will remain hopeful that a cause and cure for lupus is on the horizon.
Together we celebrate this momentous occasion for it was only together that we made it to this day. To each of you that have given of your heart, voice, time, or funds to support those living with lupus, we say THANK YOU, now join us in celebrating!
Good Health To You,
Suzanne Tierney
President/CEO
Lupus Foundation of America, Greater Ohio Chapter Inc.
Serving Cleveland, Cincinnati and Dayton Ohio
Lupus Foundation of America Applauds FDA Decision to Approve BENLYSTA®
First New Treatment for Lupus in 56 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 56 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."