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Health Last Updated: Mar 11th, 2011 - 15:30:48


Benlysta Earns FDA Approval to Treat Lupus
David Hope
Mar 10, 2011, 07:06

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Benlysta has been approved by the United States Food and Drug Administration to treat lupus. The landmark drug is the first drug to be approved to treat the life-threatening auto-immune disorder in over fifty years.

According to WebMD, the drug will most help those with mild-to-moderate symptoms. The medical website explains that these patients in the middle category have the hardest time finding treatment as aggressive treatments may cause severe side effects for them, other treatment options are too mild to relieve their symptoms.

Benlysta will be administered directly into a vein in order to target abnormal B cells, a perceived problem amongst lupus patients.

The drug was approved after two clinical trials involving over 1,600 patients proved Benlysta's effectiveness and safety.

�Benlysta, when used with existing therapies, may be an important new treatment approach for health care professionals and patients looking to help manage symptoms associated with this disease,� said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA�s Center for Drug Evaluation and Research, in a press release.

Most common side effects of the drug have been nausea, diarrhea and fever.

The drug will be marketed by Human Genome Sciences Incorporated and GlaxoSmithKline.






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