Shire has reported a positive outcome from the European Decentralised Procedure (DCP) for Elvanse (lisdexamfetamine dimesylate), which is indicated as part of a comprehensive treatment programme for attention deficit hyperactivity disorder (ADHD) in children aged six years of age and over when response to previous methylphenidate treatment is considered clinically inadequate.
The UK's MHRA acted as the reference member state on behalf of seven other European countries participating in the procedure (Denmark, Finland, Germany, Ireland, Norway, Spain and Sweden). Product labelling has been agreed by these countries, which will now issue their national Marketing Authorisations; this typically takes a further one to three months. In some countries, negotiations with national pricing and reimbursement authorities will be required before the medicine is made available to patients; the timing for this process varies between countries.
Elvanse was accepted for review by the MHRA in January 2012, with the application based on two European Phase III studies in children and adolescents with ADHD, and further supported by clinical data from the US. It is a long-acting, once-daily medication for the control of the symptoms of ADHD. Elvanse is the first of a new class of dopamine modulators approved in Europe that uses prodrug technology to release the active drug in the body. The inactive prodrug is absorbed from the gut into the bloodstream, where it is gradually converted to the active part of the medicine, d-amphetamine. The active part of Elvanse is thought to work by increasing the levels of neurotransmitters responsible for activity, attention and concentration.
The product is currently available in the US and Canada under the tradename, Vyvanse, for the treatment of ADHD in children, adolescents and adults; and in Brazil, under the tradename, Venvanse, for the treatment of ADHD in children aged six to 12 years. The efficacy and safety of the drug has been studied in many clinical trials. Elvanse will be marketed as Tyvense in Ireland.