Mircera Reviewers Turned To Top-Level FDA Briefing With CRP Concerns
This article was originally published in Pharmaceutical Approvals Monthly
Unlike trials of other ESAs, Roche’s Mircera studies excluded patients with elevated levels of C-reactive protein, a marker for inflammation. In a move reflective of growing use of interdisciplinary and cross-division expertise within FDA, the review division sought center-level “regulatory briefing” to determine if CRP screening produced a database that was not characteristic of the market. The briefing found the rate of exclusion due to CRP screening insufficient to delay approval of Mircera
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