Roseville, Minn.-based Rebiotix has been granted FDA breakthrough therapy status for its lead product RBX2660 to treat recurrent Clostridium difficile infection.
The designation entitles Rebiotix to early and frequent support from FDA senior managers and reviewers in designing a drug development plan that will speed the approval timeline.
This is the third regulatory milestone for RBX2660, which previously was granted orphan drug status and fast-track status by the FDA.
RBX2660 works by delivering human-derived microbes into a patient’s intestinal tract, restoring the balance of microbes that is typically disrupted by antibiotic use. C. difficile causes more than 29,000 deaths each year in the U.S. — Kellen Owings