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Vowst represents the first oral live microbiota therapeutic approved for recurrent C. difficile infections.
With the April 26 approval of Vowst (fecal microbiota spores, live-brpk), the US Food and Drug Administration (FDA) is signaling that the future of treatments for recurrent Clostridioides difficile infections (rCDI) might be live microbiota therapeutics.
Vowst, which was originally called SER-109, is an oral capsule that contains purified firmicutes spores that has shown clinical promise at preventing recurrence for patients at a risk of rCDI.
The approval also marks the second time in 6 months the FDA gave a green light to a live microbiota therapeutic after November’s approval for RBX2660 for the same indication.
In an interview with HCPLive®, Sahil Khanna, MBBS, MS, Division of Gastroenterology and Hepatology, Mayo Clinic and an investigator on recent Vowst trials, explained that with 2 therapeutic options, doctors, patients, and payers will not benefit from choices.
“I think we are at a very exciting time for management of recurrent C difficile infections,” Khanna said. “We now have for the very first time not 1, but 2 microbiome based therapies for management of recurrent C. difficile infection. It’s a huge win for our patients, it’s a huge win for our providers.”
Khanna also commented on how far the field has come in just a few short years, where rCDI was treated with antibiotics a decade ago to the success of fecal microbiota transplantation in recent years to the current state of live microbiota therapeutics.
While RBX2660 and Vowst do have some similarities, there are distinct differences between the 2 products, mainly that 1 is administered orally and 1 is administered rectally.