Shire plc, a global specialty biopharmaceutical company, announces the positive response from the European Decentralised Procedure (DCP) for Elvanse Adult in the three European countries participating in the procedure (UK, Denmark and Sweden).
Elvanse Adult was accepted for review by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in February 2014. The application was based on four Phase 3 studies designed to assess the efficacy and safety of Elvanse Adult in adults with ADHD.
The UK MHRA acted as the Reference Member State on behalf of the three European countries. Product labelling has been agreed by these countries, which will now issue their national Marketing Authorisations (approvals). This typically takes one to three months, however, the timing for this process varies among countries.
“We are delighted to be so close to the first European approvals of Elvanse Adult, for the UK, Denmark and Sweden,” said Dr. Philip J. Vickers, Global Head of Research and Development, Shire. “In Europe, the choice of licensed medications for diagnosed adults with ADHD is currently limited. After receipt of regulatory approval, we will work closely with the respective countries to ensure that Elvanse Adult is made available to patients as soon as possible.”
Lisdexamfetamine dimesylate is available for children six years of age and over, adolescents and adults in the USA and Canada (brand name Vyvanse) and in Brazil (brand name Venvanse).
In addition, lisdexamfetamine dimesylate is currently available in eight European countries indicated as part of a comprehensive treatment programme for ADHD in children and adolescents 6 years of age and over when response to previous methylphenidate treatment is considered clinically inadequate (brand names Elvanse/Tyvense.
CNS stimulants (amphetamines and methylphenidate-containing products) have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.
ADHD is a common psychiatric disorder in children, adolescents and adults. While commonly thought of as a childhood condition, nearly 50% of children with ADHD may continue to meet the criteria for the disorder in adulthood, based on parent report. Worldwide, 3.4% (range 1.2-7.3%) of adults aged 18-44 are thought to have ADHD based on the World Health Organization World Mental Health Survey Initiative.
Elvanse Adult is indicated as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in adult patients.
Elvanse Adult is not indicated in all adult patients and the decision to use the medicinal product must take into consideration the profile of the patient, including a thorough medical history assessment of the severity and chronicity of the patient’s symptoms, the potential for abuse, misuse or diversion and clinical response to any previous pharmacotherapies for the treatment of ADHD.