FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs / Submissions and Approvals

Astellas Wins QIDP Status for Isavuconazole

Dec. 4, 2013

The U.S. subsidiary of Astellas Pharma has received Qualified Infectious Disease Product (QIDP) designation from the FDA for its anti-fungal medication isovuconazole for invasive aspergillosis. The drug is currently in three Phase III studies evaluating its safety and efficacy for invasive fungal disease.

The QIDP designation was created under the Generating Antibiotic Incentives Now (GAIN) Act. Drugs with the QIDP designation are eligible for priority review, fast track status and, if approved, five-year patent exclusivity under Hatch-Waxman. Signed into law in July 2012 as part of the FDA Safety and Innovation Act and PDUFA V, the GAIN Act is explicitly meant to speed new antibiotics to the market as older antibiotics face drug resistance. — Lena Freund

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