Shire receives EU approval for Intuniv in paediatric ADHD treatment

Shire has announced that its  once-daily, non-stimulant drug Intuniv has been approved in Europe for the treatment of paediatric attention deficit hyperactivity disorder (ADHD).

The guanfacine hydrochloride prolonged release tablets have been ratified by the European Commission for the treatment of ADHD in children and adolescents aged six to 17 years for whom stimulants are not suitable, not tolerated or have been shown to be ineffective.

This approval is based on data from three pivotal phase III studies that have demonstrated the short and long-term safety and efficacy of this drug in paediatric patients with ADHD.

Intuniv is designed to be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures.

Perry Sternberg, senior vice-president of Shire's neuroscience business, 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."

This comes after the firm recently launched its second annual Excellence in ADHD Patient Group Awards, building on the success of last year's inaugural event.