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

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

  • By

  • Bernat Olle

  • Ryan Ranallo

  • L Clifford McDonald

  • November 20, 2024

  • 0 min

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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.

Original Source(s)

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

  • by Bernat Olle, Ryan Ranallo, L Clifford McDonald

  • November 20, 2024

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