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Shire receives European approval for INTUNIV as a non-stimulant ADHD treatment for children and adolescents

Shire has announced that the European Commission granted Marketing Authorisation for once-daily, non-stimulant INTUNIV® (guanfacine hydrochloride prolonged release tablets) 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.1 INTUNIV must be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures.1

“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,” said Perry Sternberg, Senior Vice President, Neuroscience Business Unit, Shire. “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 decision to grant approval is based on data from three pivotal Phase 3 studies investigating the short- and long-term safety and efficacy of INTUNIV in children and adolescents with ADHD.2-4

The European Commission decision to grant Marketing Authorisation follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) in July 2015 and applies to all 28 EU member states and Iceland, Liechtenstein and Norway.

About ADHD in children and adolescents

ADHD is a common psychiatric disorder in children and adolescents5-7and is recognised by the World Health Organization (WHO).8 The core symptoms are inattention, hyperactivity and impulsivity.7 Worldwide, prevalence of ADHD is estimated to be between 5.29% and 7.1%, and just under 5% for children and adolescents (<18 years).5,69-11

About INTUNIV

INTUNIV is indicated in the EU, Iceland, Liechtenstein and Norway as a non-stimulant for the treatment of ADHD in children and adolescents aged 6 to 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective.1

INTUNIV must be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures.1

Guanfacine is a selective alpha-2A adrenergic receptor agonist in that it has 15-20 times higher affinity for this receptor subtype than for the alpha-2B or alpha-2C subtypes.1 Guanfacine is a non-stimulant. The mode of action of guanfacine in ADHD is not fully established. Preclinical research suggests guanfacine modulates signalling in the prefrontal cortex and basal ganglia through direct modification of synaptic noradrenalin transmission at the alpha 2- adrenergic receptors.1

The effects of guanfacine in the treatment of ADHD have been examined in children and adolescents (6 to 17 years). Guanfacine showed significantly greater efficacy than placebo on symptoms of ADHD based upon investigator ratings on the ADHD Rating Scale (ADHD-RS).1

INTUNIV is also licensed in the US and Canada. For more information on the product labelling in these markets, refer to the US Prescribing Information and the Canadian Product Monograph, respectively. In the US, generic versions of Intuniv for the treatment of ADHD are available.