SER-109 Is Now FDA-Approved to Treat Recurrent C difficile Infection


Vowst (SER-109) has received FDA approval to treat recurrent C diff infection, making it the first oral microbiome therapeutic.

SER-109 has received FDA approval to treat recurrent C diff infection, making it the first oral microbiome therapeutic.

Today, April 26, the US Food and Drug Administration (FDA) approved the oral microbiota treatment Vowst (SER-109) to prevent recurrent Clostridioides difficile (C diff) infection.

The highly anticipated Biologics License Acceptance comes on SER-109’s Prescription Drug User Fee Act (PDUFA) action date. With today's decision, SER-109 becomes the first-ever FDA-approved oral microbiome therapeutic.

SER-109 was developed by the biotechnology company Seres Therapeutics, and works to restore the gut by competing metabolically with C diff and restoring colonization resistance.

“The restoration of the microbiota is going to be one of the most essential things,” said Andrew Skinner, MD, an assistant professor at Loyola Medical Center in Chicago. “Once we do restore a normal microbiota, we do know that there’s something called colonization resistance, which is going to be critical in preventing further C difficile infections.”

C diff is a bacterium that can cause debilitating disease, particularly in individuals who are older, immunocompromised, and/or hospitalized. If not fatal, C diff infection (CDI) can cause diarrhea, fever, stomach pain, loss of appetite, and nausea. C diff causes uncomfortable and embarrassing physical symptoms, but CDI patients also frequently report poor health-related quality of life, loss of productivity, anxiety, and depression.

In addition to the tremendous burden on patients, CDI significantly strains health care professionals and hospital resources. About 20-36% of CDI patients experience a recurrence, and each recurrent CDI becomes more deadly and increases the risk of subsequent recurrences.

There are drugs, such as fidaxomicin and vancomycin, that effectively kill C diff spores. However, they are so powerful that they may actually further decimate the gut microbiome.

“When you’re done with your antibiotics, you still will have dysbiosis,” said John Reilly, BA, PharmD, residency program director and clinical specialist of infectious disease. “It’s the dysbiosis that leads to the recurrences of C diff.”

SER-109 aims to restore the damaged microbiome. “It’s a very novel treatment approach,” emphasized Reilly.

To give practitioners’ insights into this approval, Contagion interviewed Joseph Reilly, BS, PharmD, and Andrew Skinner, MD. Reilly and Skinner both have significant experience caring for patients with CDI and recurrent CDI, and share how the FDA approval of SER-109 will change their treatment of these patients.

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