Shire files sNDA at FDA for Vyvanse to manage Binge Eating Disorder

Shire plc has announced that the FDA has accepted for filing with priority review a supplemental New Drug Application (sNDA) for Vyvanse (lisdexamfetamine dimesylate) Capsules (CII) as a treatment for adults with Binge Eating Disorder (BED). The FDA is expected to provide a decision in February 2015, based on the anticipated Prescription Drug User Fee Act (PDUFA) action date.

BED is a distinct eating disorder now recognized in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). BED is characterized by recurring episodes of eating significantly larger amounts of food in a discrete period of time (eg, any two-hour period) than most people would eat in a similar period of time under similar circumstances.These episodes are associated with feelings of distress and lack of control (eg, the sense one cannot stop eating or control what or how much one is eating).