Shire gets priority review for its Vyvanse sNDA in binge eating from FDA

Ireland-headquartered drugmaker Shire (LSE: SHP) has received acceptance for its filing with priority review a supplemental New Drug Application for Vyvanse (lisdexamfetamine dimesylate) as a treatment for adults with binge-eating disorder.

The US Food and Drug Administration is expected to make its decision in February 2015, based on the anticipated Prescription Drug User Fee Act action date. Vyvanse is currently approved for attention-deficit hyperactivity disorder (ADHD) only, and Shire is seeking approval for the drug as treatment for binge-eating based on the results of two randomized placebo-controlled Phase III studies.

Phil Vickers, head of R&D at Shire, said: “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.”