FDA Expedites Review Of Local Co.’s Intestinal Treatment
The U.S. Food and Drug Administration (FDA) has expedited the review of Rebiotix, Inc.’s, microbiota product as treatment for a potentially fatal infection.
Roseville-based Rebiotix developed RBX2660—a pre-screened, intestinal preparation that contains live microbes—to treat the recurrent Clostridium difficile infection (CDI). According to the company, CDI accounts for more than 14,000 deaths annually in the United States. It is primarily characterized by loose stool and abdominal pain. Most cases of CDI occur after the natural microorganisms in the intestinal lining have been disrupted by antibiotic use.
The treatment has been accepted into the FDA’s Fast Track program, which was designed to accelerate the review process for new drugs and treatments that could treat serious or fatal illnesses. To qualify for the Fast Track designation, a product must meet criteria such as addressing a serious or life-threatening condition and demonstrating the potential to address unmet medical needs.
Rebiotix’s treatment builds off of an existing fecal transplant procedure. Fecal transplant is a process in which a healthy person’s microbes populate the sick patient’s intestines. However, the former, non-standardized fecal transplant process is expensive and involves time-consuming donor screening and unappealing sample preparation, according to Rebiotix. The company says its new product would be physician-friendly, ready-to-use, and available for order as needed.
“We’re pleased to have received the Fast Track designation and look forward to working closely with the FDA as RBX2660 is developed,” Rebiotix CEO Lee Jones said in a statement. “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.”
Rebiotix, formerly known as Mikrobex, develops treatments for gastrointestinal diseases. In 2010, Twin Cities Business named Michael Berman, the co-founder and chairman of Rebiotix, to its Minnesota Business Hall of Fame. Click here to read about Berman’s involvement in the health care industry.