USA – FDA Drafts Guidance on Developing Drugs for Rare Chronic Digestive Disorder

The US Food and Drug Administration (FDA) issued draft guidance on Wednesday to aid sponsors in the clinical development of drugs and biologics for the treatment of eosinophilic esophagitis (EoE).

The 13-page draft guidance document describes the agency’s clinical trial recommendations for EoE drugs. These relate to trial population and design, safety and efficacy considerations, clinical outcomes assessments, as well as pediatric considerations. The clinical development of drugs for the treatment of non-EoE eosinophilic gastrointestinal disorders falls outside of the scope of the agency’s draft guidance.

FDA recommends sponsors “consider stratified randomization based on the presence or absence of baseline strictures” when making population determinations…