Rebiotix Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of RBX2660 (microbiota suspension), intended for the treatment of recurrent Clostridium difficile infection (CDI). The FDA's Fast Track program is designed to facilitate the development and expedite the review of new drugs or biologic products that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
“This designation reinforces the urgent need for a new therapy for recurrent CDI to treat patients who have this debilitating and potentially life-threatening disease.”
CDI, which is characterized by watery diarrhea and abdominal pain, has been linked to over 14,000 deaths annually in the U.S. and has become the most common healthcare-associated infection in some parts of the country, surpassing methicillin-resistant Staphylococcus aureus (MRSA) infections. Currently, there are few evidence-based approaches to the treatment of multiply-recurrent CDI.
"We're pleased to have received the Fast Track designation and look forward to working closely with the FDA as RBX2660 is developed," said Rebiotix CEO Lee Jones. "This designation reinforces the urgent need for a new therapy for recurrent CDI to treat patients who have this debilitating and potentially life-threatening disease." Patients with recurrent CDI often have to endure months of illness and only feel better when they are taking antibiotics. Once the antibiotic therapy stops, the disease process often begins again, disrupting their lives.
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