FDA’s Fecal Transplant Enforcement Discretion May Jeopardize Rebiotix’s Approval Prospects

A 2013 FDA decision to allow certain fecal microbiota transplants for C. difficile infection without an investigational new drug application hurt Rebiotix’s Phase III trial enrollment and may ultimately leave it without strong enough data for advisory committee endorsement or FDA approval.

person clutching stomach — Rebiotix’s fecal microbiota transplant looks to face uphill fight at FDA advisory committee 22 September • Source: Shutterstock

Ferring Pharmaceuticals’s fecal microbiota transplant product looks to be facing an uphill battle for US Food and Drug Administration approval due in part to an FDA policy that complicated the company’s ability to conduct two placebo-controlled Phase III trials.

Rebyota, or RBX2660, will go before the agency’s Vaccines and Related Biological Products Advisory Committee on 22 September seeking approval...