7th Apr 2015 06:30
SAINT HELIER (Alliance News) - Shire PLC on Tuesday announced that it has reached an agreement with the US Food and Drug Administration or FDA on a clear regulatory path for SHP465, an investigational oral stimulant medication being evaluated as a potential treatment for Attention-Deficit/Hyperactivity Disorder or ADHD in adults.
Shire said it has agreed with the FDA to conduct a short-term efficacy and safety study in pediatric patients with ADHD. While Shire intends to pursue an adult indication, the FDA is requesting this additional pediatric data to better understand the potential effects of SHP465 on children with ADHD in the event of use in this population. The Company anticipates the clinical trial's first patient, first visit to take place in August 2015, with study completion targeted by the last quarter of 2016.
The company then expects to submit to the FDA by second quarter 2017 a Class 2 resubmission for approval of SHP465 as a treatment for ADHD in adults, which typically entails a 6-month review. Pending FDA approval, Shire anticipates launching the medicine in the second half of 2017.
Copyright RTT News/dpa-AFX
Related Shares:
Shire