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news.The European Commission (EC) has granted marketing authorisation for Shire's Intuniv (guanfacine hydrochloride prolonged release tablets) as a non-stimulant attention deficit hyperactivity disorder (ADHD) treatment for children and adolescents.
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Intuniv, a drug for the treatment of ADHD in children and adolescents from 6 to 17 years old, is already licensed in the US and Canada.
Shire said Shire should be used as a part of a ADHD treatment program, including psychological, educational and social measures.
The company carried out three pivotal phase 3 studies evaluating the short- and long-term safety and efficacy of Intuniv in children and adolescents with ADHD.
The EC’s decision to grant marketing authorisation applies to all 28 EU member states and Iceland, Liechtenstein and Norway.
Shire senior vice president of neuroscience business unit Perry Sternberg said: "The approval of INTUNIV marks a significant advance in the treatment of ADHD in children and adolescents in Europe. Previously, physicians had only one licensed non-stimulant option for these patients.
"The importance of simply providing physicians with the ability to choose the non-stimulant option that may best suit the needs of their patients should not be overlooked, considering the complexities and different manifestations of the disorder in children and adolescents."
In July this year, the Committee for Medicinal Products for Human Use adopted a positive opinion recommending the approval of the once-daily, non-stimulant Intuniv.
Intuniv features the active substance guanfacine, a selective alpha-2A adrenergic receptor agonist.
Studies have indicated that guanfacine may exert physiological effects by stimulating the alpha-2A adrenergic receptor in the prefrontal cortex.