* Should be approved by eight European countries in months
* Most prescribed branded ADHD drug
* Indicated for children over 6 after previous treatment
By Paul Sandle
LONDON, Dec 18 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 under the European Union's decentralised
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 EU countries - Denmark, Finland, Germany,
Ireland, Norway, Spain and Sweden - participated, and they have
agreed product labels. They will now issue their own national
approvals, a process that takes up to three months, Shire said.
Chief executive Angus Russell 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".
Shire has established a leading position in treating
hyperactivity in the United States with its stimulants Adderall
XR and Vyvanse. The latter saw sales rise 24 percent to $247
million in the three months to September.
Shore Capital analyst Brian White said while he had modest
sales expectations in the short term for the drug in Europe,
where it will be the first amphetamine to be approved for ADHD,
the decision was significant because the condition was becoming
better known in Europe.
"Shire has been very successful in the U.S. with its ADHD
franchise and one would expect them to use that experience to do
a similar job in Europe, although that will take a lot longer
just given the much lower awareness," he said.
"They have another product coming along later (Intuniv)
which is a non-stimulant, and that could be more appropriate for
the European market than a stimulant."
Vyvanse, which Shire said was the top-selling branded
prescribed ADHD medicine in the United States, has been
indicated in Europe for ADHD in children aged six years and over
when treatment with methylphenidate, better known as Ritalin,
was not successful.