CDI Market Snapshot: Microbiome Therapies Begin Descent On Landscape

The recent US approval of Ferring’s microbiome-targeting Rebyota is set to change the treatment landscape for recurrent Clostridioides difficile infection and could be the proving ground for this class of agents. Rebyota is the first microbiome-targeting treatment to reach the market, but several promising candidates for the same indication are waiting in the wings.

Microbiome Treatments Come Of Age • Source: Shutterstock

Clostridioides difficile infection (CDI) is a billion-dollar problem that microbiome-targeted companies are keen to solve. CDI is arguably the lowest-hanging fruit for microbiome-focused companies as there is a clear rationale for treating a dysbiotic gastrointestinal tract through a microbial restoration approach, and there is a history of doing so effectively with fecal microbiota transplantation (FMT). What’s more, clinicians, patients and regulators are hungry for an equally effective but safer and more palatable alternative to FMT.

Now, the US Food and Drug Administration has approved the first such therapy, giving the green light to Ferring Pharmaceuticals’s Rebyota on 30 November 2022 (Also see "Ferring Makes Important Milestone For Microbiome With Rebyota Approval" - Scrip, 1 December, 2022.)

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