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HGS files Benlysta in US

This article was originally published in Scrip

Executive Summary

Human Genome Sciences has filed a BLA for Benlysta (belimumab) in the US for the treatment of systemic lupus erythematosus (SLE) in patients who are autoantibody-positive. The US filing is good news for the company after it previously admitted that it might not be able to meet its second quarter submission target for the product because of the increased analytical work needed following its failure to meet a key secondary endpoint in the pivotal BLISS-76 study (ie, patient response rate at week 76;, 26 April 2010).



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