ADHD drug Intuniv now approved for adults in Japan

Shares of Japanese pharma major Shionogi (TYO: 4501) were up 1.1% at 6,177 yen today, after the company announced the approval for Intuniv (guanfacine hydrochloride) for the treatment of attention deficit hyperactivity disorder (ADHD) with an additional indication in adult patients in its domestic market.

The company filed for the additional adult use in Japan in August last year. Intuniv is partnered with originator Shire, which is now a unit of Japan’s largest drugmaker Takeda (TYO: 4502), under a 2011 agreement.

Intunivis a ‘selective α2A adrenergic receptor agonist’, firstly approved as a drug for ADHD with this mechanism of action, and Intuniv is a non-central nervous system stimulant that is to be administered once daily and has been approved as a drug for ADHD in pediatric patients (6 to 17 years old) in 36countries including Japan (as of March 2018).

In Japan, Shionogi launched Intuniv for the indication of ADHD in pediatric patients on May 2017. Shionogi conducted the clinical studies of the drug in adult ADHD patients (18 years old and over) in Japan first in the world. Intuniv demonstrated a statistically-significant improvement compared with placebo in the primary endpoint of ADHD evaluation scale.