Shire submits INTUNIV® (guanfacine extended release) Marketing Authorisation Application to EMA
Posted: 1 April 2014 | | No comments yet
Shire plc announced the acceptance of submission of a Marketing Authorisation Application by the European Medicines Agency for their once-daily, non-stimulant guanfacine extended release…
Shire plc (LSE: SHP, NASDAQ: SHPG) today announced the acceptance of submission of a Marketing Authorisation Application (MAA) by the European Medicines Agency (EMA) for their once-daily, non-stimulant guanfacine extended release for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD) in children/adolescents aged 6-17 years.
“The regulatory submission of guanfacine extended release brings Shire one step closer to providing an alternative to stimulant medication for the treatment of ADHD,” said Perry Sternberg, Senior Vice President of the Neuroscience Business Unit at Shire. “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.”
Evidence for the submission is based on three pivotal studies investigating the short and longterm safety and efficacy profile of guanfacine extended release.1-3
References
- Hervas A. Guanfacine XR (GXR) for Children and Adolescents with Attention-deficit/Hyperactivity Disorder (ADHD): Phase 3, Randomized, Double-blind, Multicenter, Placebo- and Active-reference Study. Poster presented at the European Congress of Psychiatry, Munich, Germany, 1-4 March 2014.
- Newcorn J. Long-term Maintenance of Efficacy of Extended-release Guanfacine Hydrochloride (GXR) in Children and Adolescents with Attention-deficit/Hyperactivity Disorder (ADHD): Double-blind, Placebocontrolled, Multicentre, Phase 3 Randomized Withdrawal Study. Poster presented at the European Congress of Psychiatry, Munich, Germany, 1-4 March 2014.
- NCT01081132. A Phase 3, Double-blind, Randomized, Multi-center, Placebo Controlled, Dose-optimization Study Evaluating the Safety, Efficacy, and Tolerability of Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Adolescents Aged 13-17 Years Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD). http://clinicaltrials.gov/ct2/show/NCT01081132?term=spd503-312&rank=1 Last accessed February 2014.
