Shionogi files NDA in Japan for ADHD treatment for children

Japan’s Shionogi (TYO: 4507) has submitted a New Drug Application for the manufacturing and marketing in Japan of S-877503 (guanfacine hydrochloride prolonged release tablets; marketed in the USA as Intuniv), for the treatment of attention-deficit hyperactivity disorder (ADHD) in children. The Japanese clinical studies were conducted in children 6 to12 years old with this disorder.

Ireland-headquartered Shire (LSE: SHPL) and Shionogi, under a co-development and commercialization licensing contract signed in 2011, have been developing S-877503 as an investigational pediatric ADHD candidate. Shionogi is a Japan-based pharmaceutical company focused on the research and development of treatments for various therapeutic areas, including central nervous system disorders and infectious diseases.

"This NDA is significant for patients, Shire and Shionogi. If approved, Shire will have another key product available in Japan, increasing patient access to more of our medicines in a market incredibly important on the world's stage," said Philip Vickers, head of R&D at Shire, adding: "Fortunately, we have a strong partner for our ADHD development and commercialization efforts in Shionogi, who has been central to our growth in Japan. Shire has a number of pipeline products, in addition to S-877503, intended for Japan, so we're excited about the possibilities for addressing more unmet patient needs in this country."