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.
You may also be interested in...
The US FDA heard a lot about the structural, medical and especially financial barriers facing coccidioidomycosis, or Valley fever, drug development soon after the agency refused to qualify the rare fungal infection for priority review voucher incentives.
Firm adds third antifungal to its portfolio.
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.