Dr. Elizabeth Garner speculates the FDA approval of RBX2660 for recurrent C difficile infection will pave the way for more restorative microbiome therapies.
This is part 2 of an interview regarding the FDA approval of RBX2660 (Rebyota).
To watch part 1 of Dr. Elizabeth Garner’s interview, click here.
Last week, Ferring Pharmaceuticals announced the US Food and Drug Administration (FDA) had approved its first live microbiota product, RBX2660 (Rebyota).
This treatment, as interviewee and Ferring Chief Scientific Officer Elizabeth Garner, MD, explains, is intended to prevent recurrent Clostridioides difficile infection (CDI).
“This is indicated really for individuals who’ve had a recurrence,” Garner explained, “and now you’re giving them Rebyota to prevent that next recurrence from happening.”
Now that the gut is receiving growing acknowledgement as the epicenter of health, Garner believes RBX2660 has paved the way for more products intended to restore the microbiome. “This is likely to be a platform more than just a single indication,” she predicted. “The microbiome is thought to have potential importance in other conditions beyond just C diff.”
Just like any FDA-approved treatment, RBX2660 will be available by prescription. The product is administered rectally, by a provider, in the outpatient setting. Garner noted that Ferring is currently conducting clinical trials for oral administration of RBX2660.
“We’re super excited,” said Garner. “We’re gonna continue doing research in this space, certainly continuing to think about improvements, even in Rebyota…We’re definitely moving science forward in terms of thinking of indications even beyond C diff.”
Garner concluded by noting the next step is making this potentially life-saving treatment accessible to all patient populations. “We think it’s extremely important, so we’re working very closely with peers to talk about ensuring there’s wide access to this really important product.