US regulators have asked that Shire include paediatric data in its resubmission of SHP 465 for attention-deficit hyperactivity disorder, throwing yet another obstacle in its bid for approval.
SHP 465 (formerly SPD465) has the same active ingredient as the firm’s Adderall XR (mixed amphetamine salts) but is designed to provide symptom control for adults with ADHD for up to 16 hours as opposed to its predecessor’s 12.
The drug was first filed with the US Food and Drug Administration back in 2006, but has since failed to reach the finish line.
In April the FDA confirmed that Shire could submit SHP 465 as a Class 2 resubmission, but has now clarified that additional paediatric data would be required for this, crushing plans to refile the drug this year and launch it in the first half of 2015.
