Pharma Focus Europe

Ferring Announces U.S. FDA Advisory Committee Meeting for RBX2660 its Investigational Microbiota-Based Live Biotherapeutic

Wednesday, August 10, 2022

Ferring Pharmaceuticals today announced that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the U.S. Food and Drug Administration (FDA) will hold a meeting on September 22, 2022, to review data supporting the biologics license application (BLA) for RBX2660, a microbiota-based live biotherapeutic studied for its potential to reduce recurrent C. difficile infection (CDI) after antibiotic treatment.

“The gut microbiome is a highly diverse community of microbes that plays an essential role in human health. Emerging research has shown the promise of leveraging the microbiome to address a range of conditions, including serious diseases such as recurrent C. difficile infection,” said Elizabeth Garner, Chief Scientific Officer, Ferring Pharmaceuticals, U.S. “The cycle of recurrent CDI represents a significant public health burden, and Ferring is working to address that unmet need.”

The FDA intends to live stream the advisory committee meeting on the agency's YouTube page, and the meeting will also be webcast from the FDA website.

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