Positive response from European regulatory procedure supports Shire's Elvanse for ADHD

Ireland headquartered Shire (LSE: SHP) yesterday announced a positive outcome from the European Decentralized Procedure (DCP) for Elvanse (lisdexamfetamine dimesylate; to be known as Tyvense in Ireland). The drug is indicated as part of a comprehensive treatment program for attention deficit/hyperactivity disorder (ADHD) in children aged six years and over when response to previous methylphenidate treatment is considered clinically inadequate.

The UK Medicines and Healthcare products Regulatory Agency (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 labeling has been agreed by these countries, which will now issue their national Marketing Authorizations, which typically takes a further one to three months. In some countries, negotiations with national pricing and reimbursement authorities will now be required before the medicine is made available to patients, and 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 USA.