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BioPharmaceutical Regulation

Astellas Antifungal Isavuconazole In Line For 12-Year Exclusivity: QIDP+Orphan Combos Are Rare

This article was originally published in RPM Report

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Executive Summary

Astellas Pharma’s isavuconazole should soon become the first antifungal therapy approved with the added exclusivity award for Qualified Infectious Disease Products under the GAIN Act. It will also be the first product to receive both QIDP and Orphan Drug exclusivity – a combination that probably won’t happen often.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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