FDA’s Benlysta Approval: A Lesson In Overcoming Unvalidated Endpoints
This article was originally published in Pharmaceutical Approvals Monthly
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.
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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.