Shire's ADHD star Vyvanse scores FDA's first binge eating approval

Shire's ($SHPG) been working for a while to expand its focus beyond ADHD. And now it's expanding blockbuster drug Vyvanse beyond ADHD, too.

Flemming Ornskov, CEO of Shire

The FDA has green-lighted the med as a treatment for binge eating disorder, making it the first U.S. approved drug for the disease. And with the eating disorder affecting an estimated 2.8 million adults in the country, CEO Flemming Ornskov predicts the new indication can help it kick in an extra $200 million to $300 million toward the $10 billion sales goal he's set for 2020. Peak sales could come in significantly higher than that, he told Reuters.

The FDA go-ahead follows a 12-week study that showed Vyvanse took the average number of binge days per week down from 4.79 to less than one. Patients in the placebo arm saw a reduction to just over two days per week. A second study produced similar results, Shire said.

While Shire has diversified far beyond its flagship ADHD franchise--specifically building up a rare-disease focus with pickups of ViroPharma and, more recently, NPS Pharmaceuticals ($NPSP)--it hasn't stopped trying to get more out of its tried-and-true sellers. The Dublin drugmaker focused in on the binge eating push after Vyvanse stumbled as a depression crossover, failing to significantly outperform placebo back in 2010.

And the expansion quest won't end with the new nod, either. Last June, the company agreed to an FDA request to test Vyvanse in preschool-aged children with ADHD, with a potential 6-month pediatric exclusivity boost on the line.

- read Shire's release
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