The COMP has previously designated orphan products for the treatment of fragile X-syndrome, with the condition estimated to be affecting approximately 2 in 10,000 persons in the European Union, and being chronically debilitating in particular due to neuro-behavioural and neurodevelopmental symptoms including cognitive impairment, anxiety, irritability, social withdrawal, inattention and hyperactivity, as well as epileptic seizures [25]. This evidence concerns the gene COMP and Cognitive impairment.