Elvanse® (Lisdexamfetamine Dimesylate) Receives UK Marketing Authorisation - New Option For The Treatment Of ADHD In Children And Adolescents

Date: Feb-13-2013Shire plc (LSE: SHP, NASDAQ: SHPG) have announced that its single-daily dose long-acting prodrug stimulant, Elvanse, has been authorised by the MHRA for the treatment of ADHD in children aged 6 years and over when response to previous methylphenidate treatment is considered clinically inadequate.2

Elvanse is the first stimulant prodrug to be launched in Europe for the treatment of ADHD. It is ingested in an inactive form and subsequently activated within the body, meaning that the active part of Elvanse is gradually released over time.3 Elvanse provides a long duration of effect to help patients achieve control of their ADHD symptoms.2

ADHD is one of the most common behavioural psychiatric disorders in children and adolescents, and is recognised by the World Health Organisation,4,5,6,7 yet treatment options to help manage the symptoms of ADHD remain limited in Europe. In the UK ADHD is thought to affect 3.62% of boys and 0.85% of girls aged between five and 15 years old.1

"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.

Commenting on the authorisation, Dr David Williams, Medical Director at Shire UK said, "We are delighted that Elvanse is now licensed for use in children and adolescents with ADHD in the UK. Shire is committed to improving the understanding and treatment of ADHD and to ensuring that patients diagnosed with ADHD continue to benefit from these advances."

ADHD is a complex disorder and every patient has specific needs.8 While there is no cure for ADHD, treatment generally includes educational approaches, behavioural or other psychotherapies, and medication (depending on patient age and ADHD severity), or a combination of all of these.8

Treatments such as Elvanse are believed to work by enhancing the availability of two neurotransmitters (chemical messengers in the brain), noradrenaline and dopamine, helping to correct a presumed chemical imbalance and reduce symptoms such as inattention, impulsivity and hyperactivity.2,9

Elvanse was accepted for review by the MHRA in January 2012, with the application based on two European Phase 3 safety and efficacy studies in children and adolescents with ADHD and further supported by clinical data from the USA.10,11,12,13,14,15 Elvanse has been available in the
USA since 2007, Canada since 2010 (brand name Vyvanse®) and in Brazil since 2011 (brand name Venvanse®), where it has been used to treat over four million patients.16

Elvanse has been reviewed via the European Decentralised Procedure, in which the UK MHRA has acted as the Reference Member State. Elvanse is expected to be available in the UK in the first half of 2013. Product labelling has been agreed by the UK and the other seven countries participating in the procedure (Denmark, Finland, Germany, Ireland, Norway, Spain and Sweden) who will issue their own local Marketing Authorisations.







About the data2

As described in the Summary of Product Characteristics (SmPC), the effects of Elvanse in the treatment of ADHD have been demonstrated in international controlled trials (including European patients) in children and adolescents (6 to 17 years).

Study 3252

As described in the SmPC, 336 patients aged 6-17 years were evaluated in the pivotal
Phase 3 European Study SPD489-325. In this seven-week randomised double-blind, dose- titrated, placebo- and active-controlled study, Elvanse showed significantly greater efficacy than placebo. The placebo-adjusted mean reduction from baseline at endpoint in patients treated with Elvanse on the ADHD-RS-IV Total Score was 18.6 (phttp://clinicaltrials.gov/.

Indication and Important Safety Information2

Elvanse is indicated as part of a comprehensive treatment programme for ADHD in children aged 6 years of age and over when response to previous methylphenidate treatment is considered clinically inadequate.

Elvanse is not indicated in all children with ADHD and the decision to use the drug must be based on a very thorough assessment of the severity and chronicity of the child's symptoms in relation to the child's age and potential for abuse, misuse or diversion.

Please consult the Elvanse SmPC before prescribing, particularly in relation to abuse and dependence, pre-treatment evaluation and ongoing monitoring, cardiovascular adverse events, psychiatric adverse events, tics, long-term suppression of growth (height and weight), seizures, visual disturbance, prescribing and dispensing, and use with other sympathomimetic drugs.

Adverse reactions observed with Elvanse treatment mainly reflect side effects commonly associated with stimulant use. Very common adverse reactions include decreased appetite, insomnia, dry mouth, headache, decreased weight and upper abdominal pain.

Misuse and abuse2

Stimulants including Elvanse have a potential for abuse, misuse, dependence or diversion for non-therapeutic uses that physicians should consider when prescribing this product. Stimulants should be prescribed cautiously to patients with a history of substance abuse or dependence.

About ADHD

ADHD is one of the most common behavioural psychiatric disorders in children and adolescents and is recognised by the World Health Organisation.4,5,6,7 In the UK, ADHD is thought to affect around 3.62% of boys and 0.85% of girls.1

While the exact causes of ADHD are not fully understood, it is thought to result from complex interactions between genetic and environmental factors, with studies estimating that genetic factors explain 60 - 75% of the aetiology of ADHD.17,18

Environmental factors which may increase the risk of developing ADHD include low birth weight/prematurity, and maternal smoking during pregnancy.17

View drug information on Vyvanse.
Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.