FDA Committee Will Meet Next Month for Potential RBX2660 Approval
An FDA advisory committee will meet on September 22, 2022 to decide whether to approve a biologics license application (BLA) for Ferring’s recurrent C difficile biotherapeutic, RBX2660.
Today, Ferring Pharmaceuticals announced the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on September 22 to decide whether to support a biologics license application (BLA) for RBX2660.
RBX2660 is Ferring’s microbiota-based live biotherapeutic, designed to reduce recurrent Clostridioides difficile infection (CDI) after antibiotic treatment.
The bacteria C difficile causes serious, debilitating, and even fatal disease. CDI causes up to half a million infections and tens of thousands of deaths each year in the US alone, and the US Centers for Disease Control and Prevention (CDC) has declared CDI a public health threat.
Recurrent CDI is especially dangerous, with rates of sepsis, surgery, and mortality climbing with each reinfection. Up to 35% of CDI patients may experience recurrence, and this jumps to 65% after the first recurrence.
The BLA is a request to introduce a biologic product into interstate commerce. In submitting a BLA for RBX2660, Ferring accepts responsibility for compliance with products and establishment standards. If the BLA is approved, RBX2660 will be officially licensed by the FDA and can be marketed for use in its intended populations.
Age over 65 years, recent antibiotic use, use of acid suppressants, and recent exposure to healthcare settings all increase the risk of recurrent CDI. “The cycle of recurrent CDI represents a significant public health burden, and Ferring is working to address that unmet need,” said Elizabeth Garner, Chief Scientific Officer of Ferring.
“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,” Garner said.
RBX2660 aims to prevent recurrent CDI by restoring the microbiome and ending the cycle of antibiotic-induced dysbiosis and CDI recurrence. RBX2660 has previously been granted Fast Track, Orphan, and Breakthrough Therapy designations by the FDA.