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Home Industry News Shire files for EU approval of Intuniv for ADHD

Shire files for EU approval of Intuniv for ADHD

4th April 2014

Shire has announced the acceptance of submission of a European marketing authorisation application for a new treatment of attention deficit hyperactivity disorder (ADHD).

The European Medicines Agency will now assess the company's once-daily, non-stimulant guanfacine extended release therapy Intuniv for the treatment of ADHD in children and adolescents aged six to 17 years.

Evidence for the submission is based on positive data from three pivotal studies that underlined the short and long-term safety and efficacy profile of guanfacine extended release among patients in this group.

This treatment is already approved in the US under the name Intuniv and in Canada as Intuniv XR.

Perry Sternberg, senior vice-president of the neuroscience business unit at Shire, said: "Every patient has different needs and we hope to be able to extend our range of treatment options which will help the physician to offer personalised management of ADHD."

This comes after the company launched another clinically-proven ADHD therapy, Elvanse, in the UK last year.ADNFCR-8000103-ID-801709890-ADNFCR

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