Astellas Antifungal Nabs 12-Year Exclusivity: QIDP+Orphan Combos Are Rare
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.
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The Infectious Diseases Society of America’s “Special Population” approval mechanism has proponents within FDA and industry. That makes it look like a good balancing proposal to complement the market incentives for anti-infectives being pushed under the GAIN Act add-on to PDUFA V. There is one big hurdle, however: GAIN’s major legislative proponent, Rep. Phil Gingrey (R-GA) does not like the limitations on use post-approval.
CMS streamlined process for enhanced payments is having an impact: seven antibiotic applications for New Technology Add-On Payment status in 2021—including one for a product that has been marketed for more than five years.