Human Genome Sciences Dodges Mortality Boxed Warning, REMS For Benlysta
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Human Genome Sciences escaped a boxed label warning and a Risk Evaluation and Mitigation Strategy for its lupus drug Benlysta (belimumab), despite FDA expectations late in the review process that both would be needed.
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Review Of Reviews: Drug Review Profiles Of 2011
Each month, Pharmaceutical Approvals Monthly analyzes the FDA review process for a recent approval based on the NDA or BLA review documents. A detailed chronology of product development and listing of key reviewers accompany each profile.
FDA’s Benlysta Approval: A Lesson In Overcoming Unvalidated Endpoints
A novel composite primary endpoint created by Human Genome Sciences with FDA’s blessing helped Benlysta (belimumab) obtain approval for lupus – one of contemporary drug development’s most challenging indications – despite the absence of a standard disease outcome measure.
FDA’s Benlysta Approval: A Lesson In Overcoming Unvalidated Endpoints
A novel composite primary endpoint created by Human Genome Sciences with FDA’s blessing helped Benlysta (belimumab) obtain approval for lupus – one of contemporary drug development’s most challenging indications – despite the absence of a standard disease outcome measure.