LONDON Shire's hyperactivity treatment Vyvanse will be available in Europe within months after Britain's drugs regulator backed the amphetamine-based stimulant used to treat millions of U.S. students.
The drug, lisdexamfetamine dimesylate, has a slow-release action that activates the amphetamine ingredient over the course of a day, helping levels of alertness and concentration in children with ADHD (attention deficit hyperactivity disorder).
It was assessed in Europe under the decentralized approvals procedure, led by Britain's medicines watchdog.
The application was supported by two European studies and clinical data from the United States.
Seven other countries - Denmark, Finland, Germany, Ireland, Norway, Spain and Sweden - participated, and they have agreed product labels. The countries will now issue their own national approvals, a process that takes one to three months, Shire said.
The company's chief executive, Angus Russell, said he was delighted that national approvals for the drug, which will be known as Elvanse in Europe, were now imminent.
"ADHD is one of the most common psychiatric disorders affecting children and adolescents," he said.
"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."
The drug, which Shire said was the top-selling branded prescribed ADHD medicine in the United States, has been indicated for ADHD in children aged six years and over when treatment with methylphenidate, better known as Ritalin, is not successful.
Shares in London-listed Shire were 0.3 percent higher at 1,929 pence by 10:51 a.m. ET.
(Reporting by Paul Sandle)