Correspondence to “Escape Velocity—The Launch of Microbiome Therapies” - Takeaways - MDSpire

Response to “Escape Velocity—The Emergence of Microbiome-Based Therapies”

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1

The FDA has approved two live biotherapeutic products for preventing recurrent Clostridioides difficile infection.
2

The FDA refers to these products as fecal microbiota products, not LBPs, highlighting a terminology distinction.
3

Fecal microbiota products have variable strain compositions, differing from the defined drug substance description by the FDA.
4

The authors acknowledge previous inconsistent use of the term LBPs in their own publication regarding microbiome science.
5

Aligning terminology between academia and the FDA is essential for advancing microbiome therapeutic development.