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news.The UK Medicines Healthcare products Regulatory Agency (MHRA) has accepted Shire's application for review of an adult indication, of its once-daily Attention Deficit/Hyperactivity Disorder (ADHD) medication Elvanse (lisdexamfetamine dimesylate), for newly diagnosed adult patients.
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The MHRA has agreed to act as the Reference Member State for this Decentralised Procedure, which will include the UK, Denmark and Sweden.
Elvanse is the first long-acting prodrug stimulant for the treatment of ADHD and is currently licensed in eight European countries for the treatment of children six years of age and over when response to previous methylphenidate treatment is considered clinically inadequate.
Shire senior vice president of the Neuroscience Business Unit Perry Sternberg said the regulatory submission for the adult indication for Elvanse in Europe is a key milestone for both Shire and adults with ADHD.
"ADHD is sometimes only diagnosed in adulthood and, in Europe, the choice of licensed medications for newly diagnosed adults with ADHD is currently limited," Sternberg said.
"After receipt of regulatory approval, Elvanse will bring a new treatment option to adults with ADHD."