New Drug Application submitted in Japan for Intuniv for adults

13 August 2018

Japanese pharma major Shionogi (TYO: 4507) has submitted a New Drug Application (NDA) for the manufacture and marketing in Japan of Intuniv(guanfacine hydrochloride extended release) for the treatment of attention deficit hyperactivity disorder (ADHD) in adults.

The Japanese Phase III clinical trial was the first ever to evaluate Intuniv in adult patients (18 years and over) with ADHD. Shionogi, which has licensed rights to the drug from Ireland-headquartered Shire (LSE: SHP), a company in the throes of being acquired by Takeda (TYO: 4502), launched Intuniv in Japan for pediatric patients in Japan in May 2017.

“This is a key milestone, taking us a step closer to potentially providing Intuniv to adults in Japan in addition to the approved pediatric indication,” said Brigitte Robertson, vice president and head of global clinical development, Neuroscience, Shire. “There remains a significant need for new non-stimulant treatment options for adults being diagnosed with ADHD in Japan,” Dr Robertson added.

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