Yet more good news for Shire has come with the US Food and Drug Administration approving its attention-deficit hyperactivity disorder blockbuster Vyvanse for binge-eating disorder, the first medicine approved by the agency to treat this condition.
The agency has expanded approval on Vyvanse (lisdexamfetamine dimesylate) for adults with BED based on two Phase III studies which showed that it was statistically superior to placebo in terms of number of binge days per week. BED affects around 2.8 million US adults and is more prevalent than anorexia nervosa and bulimia nervosa combined.
Mitchell Mathis, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, noted that BED “can cause serious health problems and difficulties with work, home, and social life”. Vyvanse is “an effective option to help curb episodes of binge eating,” he added.
The approval will add to Vyvanse’s already-strong sales – $354.9 million (+19%) in the third quarter. It also ends a strong week for Shire which began with the FDA approving Natpara (recombinant human parathyroid hormone) for hypoparathyroidism from NPS Pharmaceuticals, which is in the process of being acquired by the Ireland-domiciled firm; the agency also fast-tracked Shire’s new Hunter syndrome therapy.
