Pediatric data add to Shire's ADHD package

Shire plc (LSE:SHP; NASDAQ:SHPG) said its SHP465 triple-bead mixed amphetamine salts (MAS) met the primary endpoint of improving ADHD symptoms in the Phase III SHP465-305 study to treat ADHD in children and adolescents.

Spokesperson Gwen Fisher told BioCentury that Shire hopes to resubmit an NDA by YE16 for the candidate in anticipation of a 2017 U.S. launch. She said Shire may pursue approval in adult and pediatric patients, depending on the outcome of discussions with FDA. ...