NEWS - Benlysta (belimumab) for lupus gets approval from FDA advisory panel

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Lupus Drug Benlysta Gets Thumbs Up From FDA Advisory Panel

MedicalNewsToday.com

Article Date: 17 Nov 2010 - 7:00 PST

An FDA Arthritis Advisory Committee voted 13 to 2 in favor of

approving Benlysta (belimumab), a lupus medication. The FDA (Food and

Drug Administration) Advisory Committee consists of 15 outside

experts, their recommendations are not binding, however, the FDA

nearly always goes along with what they recommend. Benlysta was

developed by GSK (Glaxokline) and Human Genome Sciences.

A Human Genome Sciences communiqué states that the Committee has

recommended the approval of Benlysta for " autoantibody-positive

patients with active systemic lupus erythematosus (SLE). "

If the FDA eventually goes ahead with Benlysta's approval for patients

with Systemic Lupus Erythematosus, which is now much more likely, it

will be the first new treatment for the condition in over half a

century. The Committee also voted that according to reviewed data, the

drug appears to be safe and effective. GSK says the FDA should make a

decision before the end of this year.

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http://www.medicalnewstoday.com/articles/208337.php

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