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BRIEF-US FDA staff raises questions on Human Genome, Glaxo lupus drug

WASHINGTON, Nov 12 (Reuters) - U.S. Food and Drug Administration staff, in documents released on Friday, said: * Various analyses of data on Human Genome Sciences Inc lupus drug Benlysta 'raise questions about the robustness of the efficacy findings' * Benlysta data 'not adequate to demonstrate efficacy in organ involvement associated with poor outcome and mortality' * Post-hoc analysis of racial subgroups given Benlysta suggest there may be reversal in direction of treatment effect in patients of African American or African heritage * Data on Human Genome, Glaxosmithkline lupus drug Benlysta 'demonstrate an inconsistent efficacy trend across different geographical regions' * Potentially slower onset of benefit and a potential lack of durability need to be considered with Benlysta * Part of study design 'may have exaggerated' difference between placebo and Benlysta for the primary endpoint analysis * Safety issues that warrant discussion at Benlysta advisory panel include deaths,infections, malignancy, suicide, infusion reactions * Robustness and clinical meaning of Benlysta efficacy findings warrant discussion * Will ask advisory panel if degree of efficacy demonstrated in Benlysta trials is worth the risks * Will ask panel if potential benefits of Benlysta outweigh anticipated risk of treatment if drug is combined with other immunosuppressive agents (Company news desk in Washington; +1 202 898 8400, washington.newsroom@thomsonreuters.com) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved.

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