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Shire ADHD treatment Intuniv gets EU approval

Published on 21/09/15 at 11:25am

The European Commission has granted marketing authorisation for Shire’s Intuniv for the treatment of ADHD in children. 

Intuniv (guanfacine hydrochloride prolonged release tablets) is a once-daily, extended-release, non-stimulant. It is the first drug of its kind – a selective alpha-2A adrenergic receptor agonist – to be licensed for the treatment of ADHD in the EU. 

Intuniv is available for children and adolescents six to 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective, and must be used as a part of a comprehensive attention deficit hyperactivity disorder (ADHD) treatment programme, typically including psychological, educational and social measures. 

ADHD is a WHO-recognised common psychiatric disorder in children and adolescents, the common symptoms of which are inattention, hyperactivity and impulsivity. Worldwide prevalence of the condition is estimated to be between about 5 and 7%, and just under 5% for children and adolescents. The disorder is believed to be caused by a combination of genetic and environmental factors. 

Perry Sternberg, senior vice president of the neuroscience business unit at Shire, comments: “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.” 

The European Commission’s decision to grant approval is based on data from three pivotal Phase III studies investigating the short and long-term safety and efficacy of Intuniv in children and adolescents with ADHD. 

Intuniv had previously received approval in the US and Canada. However Shire’s American sales of the drug are currently under threat as a result of generic competition from Sandoz, which introduced its own version to the market in June of this year. 

Actavis also launched a generic version in December 2014, after reaching a settlement with Shire whereby the Irish drugmaker received 25% of profits during Actavis’s six-month period of market exclusivity.   

Joel Levy

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