The US Food and Drug Administration has granted Shire a priority review for its attention-deficit hyperactivity disorder blockbuster Vyvanse as a potential treatment for binge eating disorder.
The company, which is in the process of being acquired by AbbVie, said the supplemental New Drug Application for Vyvanse (lisdexamfetamine dimesylate) for adults with BED has been accepted by the FDA which is expected to provide a decision in February 2015.
The filing is based on the results of two Phase III studies published last November which showed that compared to placebo, Vyvanse was statistically superior at weeks 11 to 12 in terms of number of binge days per week. Safety was consistent with the known profile established in studies in adults with ADHD.
R&D chief Phil Vickers said the decision from the FDA to accept the 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”.
Vyvasnse is already Shire’s best-selling drug by far, with first-half 2014 sales reaching $710.7 million (+19%).