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Shire gets FDA nod for first binge-eating treatment

Vyvanse already available as ADHD treatment

Vyvanse - ShireShire's big-selling Vyvanse brand has become the first drug approved in the US to help people with binge-eating disorder.

Vyvanse (lisdexamfetamine dimesylate) has been used to treat attention-deficit hyperactivity disorder (ADHD) for several years and remains Shire's top-selling product; sales rose 19% to reach more than $1bn in the first nine months of 2014, accounting for a quarter of the company's revenues.

While much of the buzz around Shire has focused on its rare disease business of late, particularly in the wake of its $5.2bn takeover deal for NPS Pharma, the company's core neuroscience business remains a key growth driver.

It has been suggested that new Vyvanse indications such as binge-eating could add up to $500m a year to the product's peak sales, although efforts to extend its uses into depression failed after clinical trials proved disappointing last year.

"Binge eating disorder is not just about eating a lot; it is that, plus being out of control and feeling bad about it," according to Perry Sternberg, head of Shire's neuroscience business unit, who notes it is the most common adult eating disorder in the US, affecting around 2.8 million people.

The condition tends to first develop in young adults, although many people do not seek help until they are in their 30s or 40s and diagnosis rates are low. At the moment treatment generally relies on behavioural change programmes, group therapy and treatment with selective serotonin reuptake inhibitor (SSRI) antidepressants.

Vyvanse's efficacy in the treatment of binge eating was shown in two clinical trials that included 724 adults with moderate-to-severe symptoms of the disorder, according to the FDA.

In the studies, participants taking Vyvanse experienced a decrease in the number of binge eating days per week and had fewer obsessive-compulsive binge eating behaviours compared to those on placebo.

"Binge eating can cause serious health problems and difficulties with work, home and social life," said Mitchell Mathis, the director of the agency's division of psychiatry products.

"The approval of Vyvanse provides physicians and patients with an effective option to help curb episodes of binge eating."

Generic rivals including Sandoz, Mylan and Actavis have attempted to secure approval of copycat version of Vyvanse in the US, but were knocked back last June when a district court found in favour of Shire's patent estate for the drug, which expires in 2023. The generic pharma companies have appealed the ruling.

Article by
Phil Taylor

2nd February 2015

From: Sales



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