Added benefit of lisdexamfetamine not proven, says German watchdog

3 September 2013

Ireland-headquartered Shire’s (LSE: SHP) Elvanse (lisdexamfetamine dimesylate) demonstrated no added benefit of the drug versus the appropriate comparator therapy, according to an assessment by the German Institute for Quality and Efficiency in Health Care (IQWiG) under the Act on the Reform of the Market for Medicinal Products (AMNOG). The manufacturer did not present any relevant studies. This was the result of the report published on September 2, 2013.

Elvanse has been approved in Germany since March 2013 as part of a comprehensive treatment program for attention deficit/hyperactivity disorder (ADHD) in children aged six years and over when response to previous treatment with the drug methylphenidate was inadequate. The drug, also sold under the Vyvanse trade name, generated second quarter 2013 global sales of $300 million, up 13% year-on-year.

Medication only as part of a comprehensive treatment program

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