- Vyvanse (lisdexamfetamine) is approved for the treatment of attention deficit hyperactivity disorder (ADHD) and is currently being assessed under a priority review designation for treatment of binge eating disorder (BED).
- Vyvanse already has an established safety profile. With respect to efficacy for BED treatment, two phase III studies have shown that it statistically decreases the number of binge days per week at weeks 11 to 12 during the study period
- Vyvanse is Shire’s top-selling drug and had revenues of $710.7 million for the first six months of 2014.
Currently, there is no treatment for BED, underscoring the urgency surrounding the review of Vyvanse for this indication. If approved, Vyvanse will be used for treating adults with the disorder.
Based on the current review schedule, a decision is expected by February 2015. AbbVie in particular has a lot to gain from a significant and novel label expansion for Vyvanse as the company is currently in the process of buying Shire in a tax-inversion merger. Analysts from Deautsche Bank have estimated that Vyvanse's binge eating sales alone could top $220 million in 2017 if the expanded indication is approved next year.