UK’s MHRA accepts Shire’s Elvanse filing for ADHD in adults

19 February 2014

Ireland-headquartered drugmaker Shire (LSE: SHP) has had an application for its once-daily attention deficit/hyperactivity disorder (ADHD) drug Elvanse (lisdexamfetamine dimesylate) accepted for an adult indication.

The application was accepted by the UK’s Medicines Healthcare products Regulatory Agency (MHRA) which has agreed to act as the Reference Member State for this Decentralized Procedure, which will include the UK, Denmark and Sweden.

Perry Sternberg, senior vice president of the Neuroscience Business Unit at Shire, 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. After receipt of regulatory approval, Elvanse will bring a new treatment option to adults with ADHD.”

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