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TheStreet Open House

Positive Response From European Regulatory Procedure Supports Approval Of Elvanse® (lisdexamfetamine Dimesylate) For ADHD

NYON, Switzerland, December 18, 2012 /PRNewswire/ --

Shire plc (LSE: SHP, NASDAQ: SHPG) today announces a positive outcome from the European Decentralised Procedure (DCP) for Elvanse ® (to be known as Tyvense ® in Ireland). Elvanse is indicated as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in children aged 6 years of age and over when response to previous methylphenidate treatment is considered clinically inadequate. [ 1 ]

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 labelling has been agreed by these countries, which will now issue their national Marketing Authorisations (approvals); this 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 3 studies in children and adolescents with ADHD and further supported by clinical data from the USA. [ 2 ] , [ 3 ]

Elvanse is a long-acting, once daily medication for the control of the symptoms of ADHD. [ 2 ] , [ 3 ] Elvanse is the first of a new class of dopamine modulators approved in Europe that uses pro-drug technology to release the active drug in the body. It is currently available in the USA and Canada under the trade name Vyvanse ®, for the treatment of ADHD in children, adolescents and adults, and in Brazil under the trade name Venvanse ®, for the treatment of ADHD in children aged 6 to 12 years.  It is currently the most prescribed branded ADHD medicine in the USA. The efficacy and safety of Elvanse has been studied in many clinical trials and Elvanse has been prescribed to treat more than 4 million patients in the USA, Brazil and Canada. [ 4 ]

"We are delighted that the national approvals of Elvanse in Europe are now imminent," said Angus Russell, CEO, Shire.  "ADHD is one of the most common psychiatric disorders affecting children and adolescents. As all ADHD patients are different and will vary in their responses to the available treatments, we believe introducing Elvanse will provide physicians with a broader range of options to help patients with ADHD manage their individual needs effectively. We will now work closely with the pricing and reimbursement authorities in the respective countries to ensure that Elvanse is made available to patients as soon as possible."

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