Shire agrees to FDA call for pediatric trials of Vyvanse for ADHD

Ireland-headquartered drugmaker Shire (LSE: SHP) says it has agreed to a written request by the US Food and Drug Administration to conduct pediatric clinical studies to investigate the potential use of Vyvanse (lisdexamfetamine dimesylate) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pre-school-age children, aged four to five.

Vyvanse is Shire’s best-selling drug,  sales of which increased 19% to $1.23 billion last year. The drug is currently only approved for the treatment of ADHD in the USA, Canada, Australia, Mexico and several European countries (trade name: Elvanse/Tyvense) and Brazil (trade name: Venvanse).

"Shire is committed to continuing to add to the scientific body of knowledge about ADHD treatment options for patients," said Philip Vickers, head of R&D at Shire. "Additional efficacy and safety data will help clinicians and parents make informed treatment decisions for preschool-age children with ADHD," he added.