Navigation Links
National report shines light on lupus 50-year treatment drought

Washington, D.C. - October 5, 2009Today, The Lewin Group, a national health care consulting firm, issued recommendations on ways to overcome the barriers that have obstructed lupus drug development resulting in no new drug approval for this disease in more than 50 years since the Eisenhower Administration. The recommendations are included in the report, "Overcoming Barriers to Drug Development in Lupus," which is the outcome of a 9-month study commissioned by the Lupus Foundation of America, Inc. (LFA). The recommendations highlight the need for a national collaborative and coordinated effort among key stakeholders, including the FDA, the National Institutes of Health (NIH), researchers and scientists from academia, the LFA, and industry, to implement a range of initiatives that would create a path forward to develop a robust arsenal of safe, effective, and more tolerable treatments for this difficult to treat and devastating disease.

The report provides recommendations for each of the key stakeholders, which include expanding federal support for medical research on lupus, assessing the existing standard of care used in clinical trials, examining the interpretation of regulations pertaining to clinical trial design and related standards of evidence used to evaluate investigational drugs for lupus, expediting the discovery and validation of lupus biomarkers, and more.

As part of the research conducted to prepare this independent report, in June 2009 more than 40 international lupus experts and thought leaders from government, industry, and the scientific community convened in Washington, DC to discuss the barriers to lupus drug development. This groundbreaking effort represents the first time leaders from all sectors with a broad range of informed opinions were brought together to address the unique challenges of lupus drug development and ways to overcome them.

Lupus is a chronic, severe autoimmune disease that affects approximately 1.5 million Americans − primarily women in their childbearing years. In its more severe form lupus can lead to kidney failure, heart attack, atherosclerosis, or even death. According to the report, lupus "stands apart" from other chronic autoimmune diseases because the majority of therapies currently used to effectively manage lupus have not been approved by the FDA for the disease. Many of these medications often have side effects that can be worse than the primary disease, including osteoporosis, weight gain, high blood pressure, diabetes, sterility, liver damage, and the increased risk of infection.

"The recommendations are a call to action requiring the efforts of all key stakeholders," said Sandra C. Raymond, LFA President and CEO. "They provide the foundation for developing and obtaining approval for the arsenal of therapies and personalized treatment that people with this perilous disease require."

The report states that the persistent lack of success of lupus clinical trials has consequences for the willingness of drug manufacturers to pursue FDA approval and indicates "some in industry perceive no clear pathway or system in place for the development of lupus therapies."

"The report findings demonstrate that the pharmaceutical and biotechnology industries cannot develop lupus treatments in a vacuum," said Rick Goulburn, Executive Vice President - Global Autoimmune Therapy Area at Vifor Pharma. "We need more collaboration and partnership across all sectors of the field, greater investment by the federal government in basic lupus research, and continued leadership from the LFA and the entire scientific community."

Lupus drug development has had many setbacks in recent years including the failure of several promising new treatments. However, much has been learned from these trials and potentially greater insight can be gained if the data is evaluated collectively.

An immediate outgrowth of the expert panel meeting held in June is the LFA Collective Data Analysis Initiative (LFA CDAI), chaired by Kenneth Kalunian, M.D., Professor of Medicine, Division of Rheumatology, Allergy and Immunology, at the University of California, San Diego, to advance the knowledge of lupus and optimize clinical trial design by researching data from previous and existing lupus clinical trials.

"The lupus community certainly recognizes the urgent need for collaboration," said Dr. Kalunian. "Following the expert panel meeting, working groups were immediately established to begin tackling the recommendations that were identified. When fully implemented, these initiatives will help gain needed insight on the issues which have plagued lupus clinical trials and develop more effective ways to design them, so ultimately lupus trials can be completed successfully."


Contact: Maggie Maloney
Lupus Foundation of America, Inc.

Related biology news :

1. International Rett Syndrome Foundation awards $2M for cutting-edge Rett syndrome research
2. National Science Foundation funds systems biology study of crop drought responses
3. IEEE-USA President endorses national innovation strategy
4. Synthetic Biology Project receives 2 National Science Foundation grants
5. National new biology initiative offers potential for remarkable and far-reaching benefits
6. International conference on endothelin
7. US National Academy of Sciences wins 2009 CAAT recognition award
8. International event brings worlds top cancer doctors to Queens
9. Forest Service to host 2nd International Conference on Forests and Water in a Changing Environment
10. EMBO pioneers pension plan for internationally mobile postdoctoral researchers
11. National assessment done on potential invasive snail and slug pests in US
Post Your Comments:
(Date:11/19/2015)... -- Although some 350 companies are actively involved in molecular ... according to Kalorama Information. These include Roche Diagnostics, Hologic, Abbott ... of the 6.1 billion-dollar molecular testing market, according to ... Diagnostic s .    ... one company and only a handful of companies can ...
(Date:11/17/2015)... 17, 2015 Paris from ... --> Paris from 17 th until ... biometrics innovation leader, has invented the first combined scanner in ... same scanning surface. Until now two different scanners were required: ... can capture both on the same surface. This innovation ...
(Date:11/17/2015)... EASTON, Mass. , Nov. 17, 2015 ... a leader in the development and sale of broadly ... the worldwide life sciences industry, today announced it has ... of its $5 million Private Placement (the "Offering"), increasing ... to $4,025,000.  One or more additional closings are expected ...
Breaking Biology News(10 mins):
(Date:11/30/2015)... -- HUYA Bioscience International, the leader in accelerating global development ... announced it has signed a Memorandum of Understanding with ... between KDDF and HUYA with the ultimate goal of ... the global market. China,s ... preclinical and clinical stage compounds. The company advances the ...
(Date:11/30/2015)... Jose, CA (PRWEB) , ... ... ... Content Intelligence Company, today announced tighter software integration with MarkLogic, the Enterprise ... where organizations maximize information to drive change. , Smartlogic’s Content Intelligence capabilities ...
(Date:11/27/2015)... PUNE, India , November 27, 2015 ... --> Growing popularity of companion ... emerging in cancer biomarkers market with pharmaceutical ... develop in-demand companion diagnostic tests. ... --> Complete report on global ...
(Date:11/25/2015)... 2 nouvelles études permettent d ... différences entre les souches bactériennes retrouvées dans la plaque ... humains . Ces recherches  ouvrent une nouvelle ... charge efficace de l,un des problèmes de santé ... .    --> 2 nouvelles études permettent d ...
Breaking Biology Technology: