EMA Provides More Guidance on Clinical Development of Drugs for Autism

The European Medicines Agency is providing more guidance to sponsors developing clinical trials for drugs to treat autism spectrum disorder.

Released last week, the draft document spells out diagnostic criteria, defines target populations and outlines clinical trial endpoints for potential new treatments.

Because of the broad nature of ASD, the document notes that it may be impossible to achieve a significant effect on all core symptoms with a single drug. Primary efficacy endpoints should show clinically relevant improvement on at least one core symptom, supported by a positive effect on global function.