US FDA adds new indication for Shire's ADHD drug Vyvanse; 1st-qtr results

Ireland-headquartered Shire (LSE: SHP) says that the US Food and Drug Administration has approved its Vyvanse (lisdexamfetamine dimesylate) capsules, (CII) as a maintenance treatment in children and adolescents with attention-deficit hyperactivity disorder (ADHD).

Vyvanse, which generated revenues of $1.03 billion in 2013, is currently approved as a maintenance treatment in adults with ADHD. With this new approval, Vyvanse becomes the only stimulant approved for maintenance treatment in children, adolescents, and adults (patients aged six and above) with ADHD.

The approval is based on results from a 32-week study: 26 weeks of open-label treatment with Vyvanse followed by a six-week randomized withdrawal phase. The study was designed to evaluate the continued efficacy of Vyvanse in children and adolescents (aged 6 to 17 years). A significantly lower proportion of treatment failures occurred among Vyvanse patients (15.8%) compared to placebo (67.5%) at end point of the randomized withdrawal period, showing that significantly more patients treated with Vyvanse maintained ADHD symptom control compared with placebo.