Shire pharma gets FDA green light to regulatory test ADHD treatment for adults
Shares in pharma firm Shire rose 2.5% to trade at 5285p after announcing on Tuesday that it has reached an agreement with the US Food and Drug Administration (FDA) on a clear regulatory path for a potential attention-deficit/hyperactivity disorder (ADHD) treatment for adults.
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Shire said it has agreed with the FDA to conduct a short-term efficacy and safety study in pediatric patients with ADHD (ages 6-17). The data on the drug, known as SHP465, is being requested by the FDA to better understand the potential effects on children with ADHD in the event of use in this population.
Shire anticipates the first visit of the clinical trial's first patient will take place in August 2015, with study completion targeted by the last quarter of 2016. Shire added that it intends to pursue an adult indication.
Shire then expects to submit to the FDA by the second quarter of 2017 a Class 2 re-submission for approval of SHP465 as a treatment for ADHD in adults, which typically entails a six-month review. Pending FDA approval, Shire anticipates launching the medicine in the second half of 2017.
"We believe SHP465 has the potential to be an important treatment option for adults with ADHD, which is why we worked so diligently with the FDA to determine what additional clinical data would be necessary for Shire to finalize our re-submission plans for this medicine," said Philip J. Vickers, head of research and development at Shire.
"We're pleased that we now have a clear regulatory path to bring this investigational medicine forward as a potential treatment option for adults with ADHD,” Vickers added.