Mircera Reviewers Turned To Top-Level FDA Briefing With CRP Concerns
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
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
You may also be interested in...
Cimzia Met "Minimum Necessary" CDER Standard With CBER-Advised Trials
Insufficient clinical evidence for one aspect of Cimzia’s Crohn’s disease indication came close to derailing FDA’s review of the UCB biologic, but approval was salvaged by FDA’s interest in maintaining consistency between its drugs and biologics centers in agreements made with sponsors during development.
Mircera Review Provided FDA With Forum To Suggest Ideal ESA Studies
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.
Relistor Review Offers Glimpse Into FDA’s Evolving Approach To QT Studies
FDA’s review of Wyeth and Progenics’ Relistor (methylnaltrexone) illustrates the agency’s efforts to improve its review of the "thorough QT studies" that FDA requires for all new chemical entities.