LONDON (Alliance News) - Irish drugmaker Shire PLC said on Monday its Japanese partner Shionogi & Co Ltd has submitted a new drug application for the manufacture and marketing of Intuniv in Japan.
The application is for the use of the drug to treat attention deficit hyperactivity disorder in adults, and has already been approved for use as treatment by those in the age of six to 17 years old since March 2017.
A phase three clinical trial was conducted to evaluate the results of using Intuniv in adults, which met its primary endpoint by demonstrating superiority over placebo in the improvement of ADHD symptoms.
ADHD can be characterised by three core symptoms of inattention, hyperactivity or impulsivity, or a combination of these symptoms and can have an adverse impact on major areas of life, including school and work.
Intuniv has been co-developed and commercialised by Shionogi and Shire, under a licensing contract first signed in 2011. The drug is currently approved in 36 countries, including Australia, Canada, Switzerland and the US.
"This is a key milestone, taking us a step closer to potentially providing INTUNIV to adults in Japan in addition to the approved paediatric indication. There remains a significant need for new non-stimulant treatment options for adults being diagnosed with ADHD in Japan," said Brigitte Robertson, head of Global Clinical Development in the Neuroscience segment of Shire.
Shares in FTSE 100-listed Shire were up 0.4% at 4,468.00 pence on Monday.
