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Mircera Review Provided FDA With Forum To Suggest Ideal ESA Studies

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

With FDA’s review of Roche’s Mircera BLA, the agency went beyond the normal evaluation leading to approval of the drug; it seized the opportunity to weigh in on the proper development of erythropoiesis-stimulating agents.

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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

Mircera Reviewers Turned To Top-Level FDA Briefing With CRP Concerns

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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