Elvanse Adult (lisdexamfetamine dimesylate) receives positive response from European Decentralised Procedure for Adult use in ADHD-Shire

Shire plc has announced 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 III 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.

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). Elvanse Adult is indicated as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in adult patients).