Celiac disease: FDA offers guidance on drug development (RAPS)

The US Food and Drug Administration (FDA) on Friday issued a draft guidance to industry on developing drugs or biologics to treat celiac disease (CeD) as a complement to a gluten-free diet.

The guidance was developed by FDA’s Division of Gastroenterology in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The document includes details on eligibility criteria, trial design, considerations for efficacy and safety, and clinical outcome assessments. It does not address the development of drugs intended to replace a gluten-free diet or for treating asymptomatic patients with minimal histologic inflammation.