Shire Announces FDA Acceptance for Filing with Priority Review of sNDA for Adults with Binge Eating Disorder
Shire has announced that 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). FDA is expected to provide a decision in February 2015, based on the anticipated Prescription Drug User Fee Act (PDUFA) action date.
“The decision from theFDA to accept our filing for priority review not only marks progress in the development of Vyvanse for adults with BED, but underscores this is an area of unmet medical need as there are currently no approved pharmacologic options for these patients,” said Phil Vickers, PhD, Head of Research and Development, Shire.
Vyvanse is a prescription medicine currently only approved for Attention-Deficit/Hyperactivity Disorder (ADHD). Vyvanse should only be used to treat ADHD.
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