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Aventis Behring Zemaira approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Aventis Behring plans to launch its alpha-1 proteinase inhibitor Zemaira before the end of September. FDA approved the biologic July 8 for use as chronic augmentation and maintenance therapy in individuals with A1-PI deficiency and clinical evidence of emphysema. Aventis will use 50 internal sales reps, but is looking to bolster promotions with an external distribution partner. The fast-track product was submitted in January and received a priority review. Zemaira is the third AI-PI to clear FDA, following Bayer's Prolastin and Baxter's Aralast...

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