Shire ADHD Treatment Recommended by Europe's New Centralized Authorization Procedure

The European Medicines Agency (EMA) has recommended granting a marketing authorization for Shire's Intuniv (guanfacine) to treat attention deficit hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years old for whom stimulants are not suitable or tolerated or have shown to be ineffective. This is the first treatment for ADHD in the European Union (EU) to be recommended through the centralized authorization procedure.   Since the 1950s stimulants have been the standard medication therapy for ADHD. Intuniv has a different mechanism of action. It is expected to improve the symptoms by initiating a response from neurons in regions of the brain associated with attention, organisation, planning and impulse control.     During the drug evaluation, the Committee for Medicinal Products for Human Use (CHMP) sought input from external experts, both clinicians and patient’s representatives, and invited the mother of an ADHD patient and a young adult affected by ADHD to share their experience during the Committee meeting. This is part of a pilot project started in September 2014 to bring patients’ and carers’ views and values to the assessment of medicines throughout their lifecycle.