NEWS - National report shines light on lupus 50-year treatment drought

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National Report Shines Light on Lupus 50-Year Treatment Drought

Washington, D.C. - October 5, 2009 -- Today, 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.

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Read the full article here:

http://www.lupus.org/webmodules/webarticlesnet/templates/new_empty.aspx?articlei\

d=2767 & zoneid=99

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