EMA Proposes New Guidelines on Gastrointestinal Drug Development

European regulators are proposing changes to development guidelines of drugs treating the gastrointestinal disorders ulcerative colitis and Crohn’s disease to better understand how the products work in children as well as adults.

The draft guidelines note that the current recommendations only state that “studies in children are encouraged.” Regulators say they intend to evaluate whether clearer statements should be included in the guidelines as to what extent extrapolation of adult data is possible and whether criteria for extrapolation can be defined.

Toward this aim, the European Medicines Agency’s (EMA) gastroenterology drafting group recommends revising guidance on the conduct of studies to include evaluations on:

• The need for possible extrapolation of data in adult studies to children, or the need to conduct separate studies in children;
• The need to explore the pharmacokinetic/pharmacodynamic (PK/PD) relationship in pediatric drug development, including adapting the PK/PD model concerning dose findings; and
• The need for changes in the potential claims on remission and maintenance versus treatment indication in both adults and children.

The revised guidelines, once finalized, would provide both industry and regulators with information on clinical development and assessment, which would contribute to greater consistency in drug development, the EMA said.

Comments must be received by Dec. 31. Finalization is not anticipated until the second half of 2016, giving time for external consultation, according to EMA. — Jonathon Shacat

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.