Yesterday, during the 176th Vaccines and Related Biological Products Advisory Committee meeting, members backed Ferring Therapeutics microbiota biotherapeutic, Rebyota, voting to recommend it for approval to treat recurring Clostridioides difficile infections (CDI).
During the meeting, members evaluated data provided by Ferring on the drug's efficacy and ultimately determined that it could provide an alternative treatment option to patients with reoccurring CDI cases. Patients usually face a have a high mortality rate due to the bacteria's antibiotic resistant nature, and according to Ferring, Rebyota yields its therapeutic effect by replenishing or replacing disrupted microbial communities.
The therapy uses the company’s proprietary MRT drug platform, which employs “controlled manufacturing processes and quality control parameters to investigate the impact of human-derived microbiota therapies on health and disease.”