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Emergent BioSolutions Receives U.S. FDA Approval for Drug Product Manufacturing of raxibacumab at its Winnipeg, Canada Site
Globenewswireยท 2025-12-12 13:30
Core Viewpoint - Emergent BioSolutions has received FDA approval for its supplemental Biologics License Application (sBLA) to manufacture and test raxibacumab at its Winnipeg facility, enhancing its manufacturing capabilities for inhalational anthrax treatment [1][2]. Company Developments - The approval supports Emergent's multi-year transformation strategy aimed at creating a flexible and customer-focused manufacturing network [2]. - The Winnipeg facility, with over 45 years of experience, will consolidate operations alongside the Lansing, Michigan site as part of a new operational plan announced in May 2024 [2]. Product Information - Raxibacumab is indicated for treating and preventing inhalational anthrax in adults and pediatric patients when alternative therapies are unavailable [3]. - The effectiveness of raxibacumab is based on animal model studies, with no pediatric studies conducted [4]. Safety Information - Hypersensitivity reactions, including anaphylaxis, have been reported with raxibacumab administration, necessitating monitoring during infusion [5]. - Common adverse reactions in healthy adults include injection site reactions, headache, and rash, among others [6]. Company Mission - Emergent BioSolutions focuses on delivering life-saving solutions for various health threats, including anthrax, and aims to prepare communities for current and future health challenges [7].