- Earlier this month, Vyvanse (lisdexamfetamine), which was initially approved for ADHD, received FDA approval for binge-eating disorder.
- With celebrity endorsement from the likes of former tennis pro Monica Seles, as well as advocacy-group buy-in and aggressive DTP and DTC advertising, Shire is helping patients define a newly recognized disorder which affects 2.8 million people in the U.S.
- Vyvanse is Shire's top-selling drug, with almost $1.5 billion in sales in 2014.
On the upside, in 2013, the American Psychiatric Association helped almost 3 million Americans recognize their binge-eating as a legitimate disorder. On the downside, critics say that this is just another example of using amphetamines as a way to control weight—a longstanding, dangerous approach that peaked during the mid-20th century.
Although the FDA has forbidden Shire from marketing Vyvanse as an obesity treatment, it turns out that roughly 80% of people with this disorder are obese, according to information from Shire. Based on estimates from Shire CEO, Fleming Orskov, projected annual revenues for the binge-eating indication range from $200 million to $300 million.
It will also be important to keep an eye on whether or not a subsection of doctors take advantage of the new indication and begin prescribing Vyvanse off-label to their obese patients for weight maintenance.