FDA Grants QIDP and Fast Track Designations to RedHill’s Mycobacteria Antibiotic

FDA granted a Qualified Infectious Disease Product designation to RHB-104, an oral antibiotic developed by RedHill Biopharma for the treatment of nontuberculous mycobacteria infections.

The QIDP designation allows for fast-track status and priority review, and an additional five years of marketing exclusivity if approved. The infection’s course of treatment is typically prolonged and requires multi-drug regimens due to the risk of development of resistance.

RedHill is also evaluating RHB-104 in a Phase III trial for the treatment of Crohn’s disease, as well as a Phase IIa study examining the drug as an add-on therapy to interferon beta-1a in patients with relapsing remitting multiple sclerosis.