Shire receives CHMP positive opinion for ADHD drug Intuniv
Posted: 24 July 2015 |
The CHMP has adopted a positive opinion recommending the approval of Shire’s Intuniv for the treatment of ADHD in children and adolescents…
The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Shire’s Intuniv® (guanfacine hydrochloride extended release; GXR) for the treatment of attention deficit/hyperactivity disorder (ADHD) in children and adolescents.
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.”
EC to decide if it grants marketing authorisation for Intuniv
The European Commission will now consider the CHMP positive opinion in its decision of whether to grant marketing authorisation for Intuniv in Europe.
If approved in Europe, Intuniv will be indicated for the treatment of 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.
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.