Shire plc, the global specialty biopharmaceutical company, announced that the U.S. Food and Drug Administration (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.
“The decision from the FDA 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, 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.
Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep in a safe place to prevent misuse and abuse. Selling or sharing Vyvanse may harm others and is illegal.
Shire is seeking approval for Vyvanse as a treatment option for adults with BED based on the results of two identically designed randomized placebo-controlled Phase 3 studies evaluating the efficacy and safety of Vyvanse versus placebo, previously announced in a press release dated November 5, 2013.
Date: September 15, 2014