New FDA Fecal Transplant Guidance Should Ease Ferring’s Path To Commercialization
Final guidance excludes stool banks, putting in place more limited enforcement discretion regarding the requirement of an investigational new drug application for use of fecal transplants to treat C. diff infections, likely paving way for shift to any FDA-approved product.
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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.
Keeping Track: Rebyota, Rezlidhia Rev Up US FDA Approvals; New Sponsors Sought For Poziotinib, Brexafemme
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
US FDA's Vaccines and Related Biological Products Advisory Committee endorses Rebyota for recurrent C. difficile infection; most panelists prefer a product whose manufacturing will be regulated, even one with lingering concerns about efficacy or safety, over the current landscape.