Shire's once-daily ADHD drug Venvanse accepted for European review

Shire's marketing application for Venvanse (lisdexamfetamine dimesylate) has been accepted for review by UK regulator the MHRA.

If approved it would become the first amphetamine-based drug to be licensed for attention deficit hyperactivity disorder (ADHD) in Europe, where Shire has been working to overcome scepticism of the condition.

The long-acting treatment was  launched in the US, where it is marketed as Vyvanse, in July 2007 and in Brazil in 2010 as Venvanse.

Mike Yasick, senior vice president of Shire's ADHD business unit, said: “The regulatory submission of Venvanse in Europe is an important milestone for Shire and for physicians in the EU who are seeking alternative treatments to help their patients diagnosed with ADHD.

“Venvanse is an approved ADHD treatment in North and South America and has become an important resource for physicians when helping their patients manage their ADHD symptoms, We look forward to making this treatment available in Europe.”

Shire has submitted Venvanse under the European Commission's decentralised procedure, with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) acting as reference member state.

The application will initially include eight European countries and will be based on a European phase III study showing Venvanse was effective in children and adolescents with at least moderately symptomatic ADHD.

The multi-centre trial involved 336 children and adolescents aged 6 to 17 years and showed efficacy on the primary and key secondary measures compared to placebo, and a safety profile consistent with the known effects of amfetamine treatment.

The primary outcome measure was efficacy as measured by the ADHD Rating Scale IV (ADHD-RS-IV), with secondary outcome measures including the Clinical Global Impressions-Improvement scale (CGI-I) and Conners' Parent Rating Scale-Revised (CPRS-R).

Venvanse is the first long-acting prodrug stimulant to be available for ADHD and has also shown promise against depression. In December the company reported phase II trial results showing that, used along with antidepressants, Venvanse improved patients' self-reported scores in a measure of executive function.

In addition to Venvanse, Shire's ADHD portfolio includes Intuniv (guanfacine), approved in the US 2009, and Adderall XR (dextroamphetamine and amphetamine), which has been licensed in the country since 2001.

The country has been preparing for Venvanse's European launch, and entered the European ADHD market in 2009 with its acquisition of UCB's Equasym (methylphenidate hydrochloride).

Shire also gained a small team of sales and sales management personnel through the deal, which it said at the time would establish a “solid bridge” for its other ADHD treatments outside the US.