Trials & Filings

Astellas Fungal Treatment Gets QIDP Status

Could add five years of exclusivity under GAIN Act

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Astellas Pharma US, Inc., a subsidiary of Tokyo-based Astellas Pharma Inc., has received Qualified Infectious Disease Product (QIDP) designation from the FDA for isavuconazole as a for the treatment of invasive aspergillosis. QIDP status provides priority review and a five-year extension of market exclusivity if a product receiving such a designation is approved in the U.S.. These incentives were granted under the 2012 U.S. Generating Antibiotic Incentives Now (GAIN) Act as part of the FDA Safet...

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