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If approved by the FDA, RBX2660 would be the first approved live microbiota therapeutic for the treatment of recurrent CDI.
This may be the homestretch for a promising new treatment for recurrent Clostridium difficile infections (rCDI).
At the 2022 American College of Gastroenterology (ACG) Annual Meeting, there are at least 7 abstract presentations on the safety and efficacy of RBX2660, a live microbiota therapeutic for the treatment of rCDI.
The presentations come just a few weeks after the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to recommend a Biologics License Application (BLA) for the treatment. If approved, RBX2660 would be the first live microbiota therapeutic to gain FDA approval.
Paul Feuerstadt, MD, Assistant Clinical Professor of Medicine, Yale School of Medicine, an author on all 7 studies,told HCPLive®, the data is positive, even when broken down between different age and other subgroups from the PUNCH CD3 study.
In 1 of the studies, the investigators found similar proportions of patients treated with RBX2660 categorized by age and Charlson Comorbidity Index (CCI) severity scores experienced treatment emergent adverse events.
The treatment, developed by Ferring Pharmaceuticals, is aimed at reducing recurrent CDI after antibiotic usage by being administered as a pre-packaged single-dose, consisting of 150 mL microbiota suspension from individual human stool donation.