UK patients with attention deficit hyperactivity disorder (ADHD) will soon get access to a new treatment option for their condition following the approval of Shire's Elvanse in the country.
As expected, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued a green light for the use of Elvanse (lisdexamfetamine dimesylate) to treat children aged six years and over, when response to previous methylphenidate treatment is considered inadequate.
Elvanse is the first stimulant prodrug to be launched in Europe for the treatment of ADHD, and provides a long duration of effect to help patients achieve control of their symptoms, the firm said.
As well as reducing symptoms, clinical data has shown that Elvanse can significantly boost functional outcomes; 75% of subjects on Elvanse showed improvement on the Clinical Global Impression-Improvement (CGI-I) rating scale compared to 14.2% on placebo.
In addition, Shire's drug showed significant improvement in child achievement in academic performance from baseline compared to placebo (9.4 versus -1.1, respectively).
Importantly, a randomised study also showed that the drug's benefits are maintained, with treatment failure significantly lower for patients taking Elvanse (15.8%) compared to placebo (67.5%) during a six-week withdrawal period.
Treatment options limited
ADHD is one of the most common behavioural psychiatric disorders in children and adolescents, affecting around 3.62% of boys and 0.85% of girls in the UK. But, as Shire points out, treatment options for this complex remain limited.
“Every person with ADHD is different and will vary in his or her response to the available treatments. A new treatment is welcomed as it will provide a broader range of options to help people with ADHD manage their individual needs effectively,” said Dr Val Harpin, Consultant Neurodevelopmental Paediatrician, Sheffield Children’s NHS Foundation Trust.
The drug - already a blockbuster for Shire - has been on the market for ADHD in the US (as Vyvanse) since 2007, Canada since 2010, and in Brazil since 2011 (brand name Venvanse), where it has been used to treat over four million patients.