February 05, 2015
WASHINGTON - The U.S. Food and Drug Administration on Friday approved Shire Plc's stimulant Vyvanse to treat binge-eating disorder, the first product to be approved for the condition.
Vyvanse, which is currently approved to treat attention deficit hyperactivity disorder, generated sales of more than $1 billion in the first nine months of last year.
Dr. Flemming Ornskov, the company's chief executive officer, said in an interview that Shire's goal is to generate overall sales of $10 billion by 2020. Of that, he expects $200 million to $300 million to come from Vyvanse for binge-eating.
Peak annual sales could be significantly higher, he added, as awareness of the condition increases.
Binge-eating disorder, characterized by repeated episodes of uncontrolled eating, accompanied by guilt and shame, affects roughly 2.8 million people in the United States, according to Shire.
"Binge eating can cause serious health problems and difficulties with work, home, and social life," said Dr. Mitchell Mathis, director of the FDA's division of psychiatry products. "The approval of Vyvanse provides physicians and patients with an effective option to help curb episodes of binge eating."
In clinical studies, patients taking Vyvanse were shown to have significantly fewer binge days per week than those taking a placebo.
At the time of entry to the study, the average number of binge days per week was 4.79. At week 12, average binge days per week had fallen to less than one. Patients taking a placebo, by comparison, saw a reduction of little more than 2 days a week.
Vyvanse is an amphetamine which, like other amphetamines, carries the potential for abuse and addiction. They also have been associated with increase blood press sure and heart rate, sudden death, stroke, heart attack, insomnia and psychiatric side effects such as hallucinations and mania.
The drug is not approved for weight loss.
Shire has a Chesterbrook Corporate Center in Wayne, Pa.
