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Second Successful Trial for Lupus Drug

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An experimental lupus drug called Benlysta (belimumab) was effective in its second large clinical trial, and drug makers Human Genome Sciences and GlaxoSmithKline will seek European and U.S. approval of the drug in the first half of 2010.

If approved, Benlysta would be the first new treatment for lupus in more than 40 years, The New York Times reported.

Benlysta succeeded in its first clinical trial in July. But the U.S. Food and Drug Administration said a second successful trial was needed in order to win approval for the drug. While the second trial was successful, the results weren't as good as in the first trial.

"The lupus community has waited for decades for one positive phase three trial of an investigative drug developed for lupus. Now we have two," Dr. Joan T. Merrill, a lupus expert at the Oklahoma Medical Research Foundation and investigator in the trial, said in a news release issued by Human Genome Sciences and GlaxoSmithKline, The Times reported.


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