Posted by Michael Wonder on 13 Jan 2017
RedHill Biopharma announces QIDP fast track designation granted by FDA to RHB-104 for non-tuberculous Mycobacteria infections
11 January 2017 - RedHill Biopharma today announced that RHB-104 has been granted Qualified Infectious Disease Product designation by the U.S. FDA for the treatment of non-tuberculous Mycobacteria infections
The designation was granted under the FDA's Generating Antibiotic Incentives Now (GAIN) Act, which is intended to encourage development of new antibiotic drugs for the treatment of serious or life-threatening infections.
The granted Qualified Infectious Disease Product designation allows RedHill to benefit from fast track status, with an expedited development pathway for RHB-104 for the treatment of non-tuberculous Mycobacteria infections, as well as priority review, which provides for a shorter review time by the FDA of a future potential marketing application. If approved for the treatment of non-tuberculous Mycobacteria infections, RHB-104 would also receive an additional five years of U.S. market exclusivity on top of the standard exclusivity period.
RHB-104 is a proprietary and potentially ground-breaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties.
