The CHMP’s positive opinion is based on results from three Phase 3 pivotal studies investigating the short- and long-term safety and efficacy of Intuniv in children and adolescents with ADHD.
"This positive opinion from the CHMP is an important step towards providing physicians with a new therapeutic option for children and adolescents with ADHD," said Philip J. Vickers, Ph.D., Head of Research and Development, Shire.
"Due to the varying needs of patients and the different manifestations of ADHD, non-stimulant medications are an important treatment option for some patients in Europe."
The European Commission will now consider the CHMP positive opinion in its decision of whether to grant marketing authorisation for Intuniv in Europe.
ADHD is a common psychiatric disorder in children and adolescents and is recognised by the World Health Organization (WHO). The core symptoms are inattention, hyperactivity and impulsivity. In Europe, the prevalence of ADHD is estimated to be approximately 5% for children and adolescents (<18 years). While the exact origin of ADHD is not known, studies have indicated that ADHD could be associated with certain structural and functional brain abnormalities.
If approved in Europe, Intuniv will be indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective.
If approved, Intuniv must be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures.
Intuniv contains the active substance guanfacine, a selective alpha-2A adrenergic receptor agonist. Studies have suggested that guanfacine may exert physiological effects by stimulating the alpha-2A adrenergic receptor in the prefrontal cortex.
This region is known to control several cognitive functions including attention and social behaviours, and has been associated with some structural and functional abnormalities in individuals with ADHD.