Positive vote from FDA Advisory Committee for RBX 2660 to reduce the recurrence of C.difficile
Ferring Pharmaceuticals announced that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the FDA issued a positive vote for RBX 2660, an investigational microbiota-based live biotherapeutic studied for its potential to reduce recurrence of C. difficile infection (CDI) after antibiotic treatment
VRBPAC voted 13 to 4 that the data were adequate to support the effectiveness of RBX 2660 to reduce the recurrence of CDI in adults 18 years of age and older following antibiotic treatment for recurrent CDI. The Committee also voted 12 to 4 with 1 abstention that the data were adequate to support the safety of RBX 2660 when administered to adults 18 years of age and older following antibiotic treatment for recurrent CDI. The advisory committee provides recommendations to the FDA, which the agency may consider but is not required to follow, when making its decision.
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