Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that it has received further guidance from the U.S. Food and Drug Administration (FDA) on the regulatory path for SHP 465 (triple-bead mixed amphetamine salts MAS), an investigational oral stimulant medication being evaluated as a potential treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) in adults. On April 25, 2014, in written correspondence, the FDA responded to Shire's resubmission proposal package confirming that Shire could submit SHP 465 as a Class 2 resubmission. After a series of follow-up discussions, the FDA has now clarified that additional pediatric data would be required. This information will impact Shire's plans for a 2014 New Drug Application (NDA) resubmission for SHP 465.
SHP 465 has the potential to be an important treatment option for adults with ADHD, and Shire is engaging with the FDA to define the clinical data requirements.
SOURCE Shire plc