Aelis Farma receives a favorable opinion from the EMA for AEF0217 in trisomy 21

The Paediatric Committee of the European Medicines Agency (EMA) has approved the Paediatric Investigation Plan (PIP) for AEF0217, developed by Aelis Farma. Designed to treat behavioral disorders and cognitive impairments in children with Down syndrome, this first-in-class drug offers hope to affected families.

This validation covers a clinical program including patients from birth to 18 years of age, using a phased approach. The agreement strengthens the regulatory framework surrounding the development of this treatment and clarifies the path to marketing authorization in Europe.

Divided into several phases, the program will begin with teenagers and young adults, before expanding to younger children, depending on the results obtained. With the support of families and associations, this significant step reinforces Aelis Farma's progress.