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Shire wins EU approval for prolonged-release ADHD drug

First treatment in its class to be licensed for ADHD in Europe
Shire building

The European Commission has approved Shire's Intuniv for treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents.

The regulatory nod now permits patients aged six to 17 years old treatment with the non-stimulant, for whom stimulants have shown to be ineffective, unsuitable or poorly tolerated.

Intuniv (guanfacine) is a once-daily selective 2A adrenergic receptor agonist and is the first drug in its class to be licensed for ADHD in the EU. It is also only the second non-stimulant available for the specific patient groups.

Perry Sternberg, senior VP at Shire, 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 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 decision for approval comes from data in three phase III trials that investigated the safety of Intuniv in children in the long and short term.

The drug's European approval comes six years after the FDA licensed it in the US, where it now faces generic competition.

Although the mode of action for Intuniv is not fully established, preclinical research has suggested that the drug modulates signalling in the prefrontal cortex and basal ganglia through direct modification of synaptic noradrenalin transmission at the alpha 2- adrenergic receptors.

ADHD is a common psychiatric disorder in children and adolescents and is believed to have a worldwide prevalence of around 6%. Though the exact cause of the condition is not known, it is thought to derive from the interplay of genetics and environment.

Article by
Nikhil Patel

21st September 2015

From: Regulatory



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