Shire Pharmaceutical received the European Commission approval for its non-stimulant Intuniv drug for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old.
Intuniv is for those stimulants are not suitable, not tolerated or have been shown to be ineffective. The drug is used as a part of a comprehensive ADHD treatment that includes psychological, educational and social measures.
"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," said Sternberg.
The EU grant approval based on data from three pivotal studies that looked at the short and long-term safety and efficacy of Intuniv in children and adolescents with ADHD.
ADHD is a psychiatric disorder in children and adolescents with no exact origin. The symptoms such as inattention, hyperactivity and impulsivity.
Globally, the prevalence of ADHD is between 5.29 percent and 7.1 percent under 5 percent for children and adolescents.