- The FDA designates RedHill Biopharma's (NASDAQ:RDHL) RHB-104 a Qualified Infectious Disease Product (QIDP) for the treatment of Nontuberculous Mycobacteria (NTM) infections.
- QIDP status provides for accelerated review of the New Drug Application (NDA) as well as a five-year period of market exclusivity for the indication, if approved.
- The company plans to consult with the FDA on a development plan for NTM. RHB-104, a combination antibiotic, is currently in Phase 3 development for the treatment of Crohn's disease.