This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

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."

1 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG

Markets

Chart of I:DJI
DOW 16,507.92 +156.54 0.96%
S&P 500 1,974.07 +25.21 1.29%
NASDAQ 4,798.0960 +48.1170 1.01%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs