Astellas Antifungal Nabs 12-Year Exclusivity: QIDP+Orphan Combos Are Rare
• By Laura Helbling
Cresemba (isavuconazonium), the first antifungal approved with added exclusivity award for Qualified Infectious Disease Products, also becomes first product to receive both QIDP and Orphan Drug exclusivity.
Astellas Pharma Inc.’s antifungal Cresemba (isavuconazonium) isn’t a biologic – it just has the exclusivity of one.
The product’s approval on March 6 for invasive aspergillosis and invasive mucormycosis is a showcase for how FDA handles applications...
