Shire Receives CHMP Positive Opinion in Europe for Intuniv

Shire has announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of the once-daily, non-stimulant 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 III 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, Head of R&D, 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.