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FDA Approves Labeling Change for VYVANSE(R) (lisdexamfetamine dimesylate) CII to Include Supplementary Clinical Data Supporting Efficacy at 13 Hours Postdose in Children Aged 6 to 12 with ADHD
Date:6/1/2009

ADHD symptom control demonstrated from the first time point measured (1.5 hours) through 13 hours postdose

PHILADELPHIA, June 1 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) has approved a change to the prescribing information for its once-daily Attention Deficit Hyperactivity Disorder (ADHD) treatment VYVANSE(R) (lisdexamfetamine dimesylate) CII, to include supplemental data that demonstrated significant ADHD symptom control in children aged 6 to 12 from the first time point measured (1.5 hours) through 13 hours postdose. VYVANSE is now the first and only oral ADHD stimulant treatment to have 13-hour postdose efficacy data for pediatric patients included in its product labeling.

"Children with ADHD who still exhibit symptoms into the evening might need a treatment that provides a long duration of effect from morning, through homework and family time," said Michael Yasick, Senior Vice President of the ADHD Business Unit at Shire. "The FDA approval of this labeling change for VYVANSE provides important additional information for physicians on the duration of effect of VYVANSE and use as a once daily treatment option."

This update to the VYVANSE product labeling is based on a 13-hour analog classroom study that demonstrated improvements in behavior, inattention, and math test scores in children aged 6 to 12 from the first time point measured (1.5 hours) through the last time point assessed (13 hours) postdose. This study supports the results of a previous Phase 2 laboratory school study in which VYVANSE demonstrated ADHD symptom control from the first time point assessed (two hours postdose) with duration of efficacy up to 12 hours postdose. The adverse events in the 12-h
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SOURCE Shire plc
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