Younger attention-deficit hyperactivity disorder (ADHD) patients may soon be able to access Shire’s non-stimulant Intuniv within Europe after regulators agreed to review an application to market the drug for six-17 year olds.
The European Medicines Agency has accepted Shire’s submission for the once-daily, extended-release, non-stimulant guanfacine, which includes data from three pivotal studies investigating the drug’s short and long-term safety and efficacy profile.
“Every patient has different needs and we hope to be able to extend our range of treatment options which will help the healthcare professional to offer personalised management of ADHD,” said Perry Sternberg, Senior Vice President of the Neuroscience Business Unit at Shire.
Guanfacine extended release is currently approved for use in the US (as Intuniv) and Canada (as Intuniv XR) as a monotherapy in children aged six-17 and adjunctively with a stimulant medication for ADHD in children/adolescents aged six -17 in the US and aged six-12 in Canada.
